news – page 5 – eisai china lnc.-开元体育官网下载手机版

news – page 5 – eisai china lnc.-开元体育官网下载手机版

tokyo and cambridge, mass., january 30, 2023 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that an application for manufacturing and marketing approval for lecanemab (generic name, u.s. brand name: leqembi™), an anti-amyloid-β (aβ) protofibril* antibody, in japan has been designated for priority review by the japanese ministry of health, labour and welfare (mhlw). priority review in japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for priority review, the target total review period is shortened.

in japan, eisai submitted the manufacturing and marketing approval for lecanemab to the pharmaceuticals and medical devices agency (pmda) on january 16, 2023. this application is based on the results of the phase iii clarity ad study and the phase iib clinical study (study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early ad.

lecanemab selectively binds and eliminates soluble, toxic aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in ad. as such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. the clarity ad study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. in november 2022, the results of the clarity ad study were presented at and simultaneously published in , a peer-reviewed medical journal.

in the u.s., lecanemab was granted accelerated approval as a treatment for ad by the u.s. food and drug administration (fda) on january 6, 2023. on the same day, eisai submitted a supplemental biologics license application (sbla) to the fda for approval under the traditional pathway. in europe, eisai submitted a marketing authorization application (maa) to the european medicines agency (ema) on january 9, 2023 and accepted on january 26, 2023. in china, eisai initiated submission of data for a bla to the national medical products administration (nmpa) in december 2022.

eisai serves as the lead of lecanemab development and regulatory submissions globally with both eisai and biogen co-commercializing and co-promoting the product and eisai having final decision-making authority.

highest ranked global pharmaceutical company

 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has been listed in the 2023 global 100 most sustainable corporations in the world (global 100), a global ranking by canada-based media and investment advisory company, corporate knights, inc. this marks eisai’s seventh inclusion on the list. ranked 53rd, eisai was the highest ranking company among global pharmaceutical companies.

 

the global 100 evaluates the sustainability of more than 6,000 of the world’s major corporations based on various corporate initiatives in areas such as esg (environment, society and governance). since 2005, those companies ranking among the top 100 in the world have been announced each year. the global 100 is based on up to 25 key performance indicators covering esg initiatives, with the evaluations carried out based on data publicly disclosed in financial filings, integrated reports, or through other such channels. eisai was highly evaluated, particularly in indicators for enhancing employee value such as safe work environment, sick leave support system and employee retention rate.

 

eisai’s corporate concept is to give first thought to patients and the people in the daily living domain, and increase the benefits that health care provides to them as well as meet their diversified healthcare needs worldwide. based on this human health care (hhc) corporate concept, eisai is striving to sustainably enhance corporate value by strengthening its esg initiatives and increasing non-financial value.

 

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

accelerated approval is based on phase 2 data showing a reduction in amyloid-beta plaques in early ad patients treated with leqembi™

treatment with leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials

 

tokyo and cambridge, mass., january 7, 2023 eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, eisai) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, biogen) announced today that under the accelerated approval pathway the u.s. food and drug administration (fda) has approved lecanemabirmb (brand name in the u.s.: leqembi™) 100 mg/ml injection for intravenous use, a humanized immunoglobulin gamma 1 (igg1) monoclonal antibody directed against aggregated soluble (“protofibril”)* and insoluble forms of amyloid beta (aβ) for the treatment of alzheimer’s disease (ad). the approval is based on phase 2 data that demonstrated that leqembi reduced the accumulation of aβ plaque in the brain, a defining feature of ad. using the recently published data from the large global confirmatory phase 3 clinical trial, clarity ad, eisai will work quickly to file a supplemental biologics license application (sbla) to the fda for approval under the traditional pathway.

 

indication
leqembi is indicated for the treatment of alzheimer’s disease. treatment with leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. this indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with leqembi. continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.


dosage and administration (patient selection, dosing instructions, monitoring and dosing interruption for aria)
the recommended dosage of leqembi is 10 mg/kg administered intravenously once every two weeks to eligible patients with confirmed presence of aβ pathology prior to initiating treatment. enhanced clinical vigilance for amyloidrelated imaging abnormalities (aria) is recommended during the first 14 weeks of treatment with leqembi. baseline, recent (within one year) brain mri prior to initiating treatment with leqembi and periodic monitoring with mri prior to the 5th, 7th, and 14th infusions should be obtained.

 

adverse reactions
the safety of leqembi has been evaluated in 763 patients who received at least one dose of leqembi in study 201. the most common adverse reactions reported in at least 5% of patients treated with leqembi 10 mg/kg biweekly (n=161) and at least 2% higher incidence than patients on placebo (n=245) were infusionrelated reactions (leqembi 20%; placebo 3%), headache (leqembi 14%; placebo 10%), ariae (leqembi 10%; placebo 1%), cough (leqembi, 9%; placebo, 5%) and diarrhea (leqembi, 8%; placebo, 5%). the most common adverse reaction leading to discontinuation of leqembi was infusionrelated reactions that led to discontinuation in 2% (4/161) of patients treated with leqembi compared to 1% (2/245) of patients on placebo.


“the fda’s approval of leqembi under the accelerated approval pathway is an important milestone in eisai’s four decades of research in alzheimer’s disease and reflects our continued commitment to alleviating the burden of alzheimer’s disease for patients and their families. eisai has made great efforts to understand the reality of the challenges and concerns facing patients and their families who are living in the various stages of alzheimer’s disease, and we are incredibly pleased to offer leqembi as a new treatment option to help with the tremendous unmet needs of this community,” said haruo naito, chief executive officer at eisai co., ltd. “the challenges of alzheimer’s disease reach beyond medical implications for patients and considerations for their families, but also impact society as a whole through reduced productivity, elevated social costs and anxiety. upon receiving this accelerated approval, we will focus on providing important information on proper usage of leqembi to healthcare professionals. eisai will also engage with various payers to provide access to leqembi, offer a patient support program, and
will do its utmost to complete submission for traditional approval as soon as possible to serve more people living with early alzheimer’s disease.”


“the approval of leqembi provides new hope to patients with alzheimer’s disease. patients at an early stage of the disease and their caregivers can now consider a new treatment option with their doctors. our focus now is on the path forward, working alongside eisai with the goal of making leqembi available to patients who may benefit from this treatment as soon as possible,” said christopher a. viehbacher, president and chief executive officer of biogen. “this approval is also a recognition of the many scientists and doctors who have, over many years, patiently and persistently worked to find a treatment for this highly complex disease. eisai and biogen have collaborated for nearly a decade to advance research to improve the lives of those suffering from alzheimer’s, and we know that this commitment must and will continue in the fight against alzheimer’s disease.”


media contacts:
eisai co., ltd.
public relations department
tel: 81 (0)338175120


eisai inc. (u.s.)
libby holman
12017531945
libby_holman@eisai.com

 

eisai europe, ltd.
(uk, europe, australia, new zealand and russia)
emea communications department
44 (0) 786 601 1272
emea-comms@eisai.net


biogen inc.
natacha gassenbach
18577776573
public.affairs@biogen.com

investor contacts:
eisai co., ltd.
investor relations department
tel: 81 (0) 338175122


biogen inc.
mike hencke
17814642442
ir@biogen.com

tokyo and cambridge, eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that eisai has initiated submission of data for biologics license application (bla) to the national medical products administration (nmpa) of china for lecanemab (development code: ban2401), an investigational anti-amyloid beta (aβ) protofibril antibody.

the registration category of lecanemab was designated as a category 1 drug (innovative biologics not approved in china or any other countries).

the data submitted in this package includes data from the phase ii clinical trial (study 201) in mild cognitive impairment (mci) due to alzheimer’s disease (ad) and mild ad (collectively known as early ad) with confirmed aβ accumulation in the brain and the top-line data of the large global phase iii clarity ad study. eisai will submit additional data including full data of the clarity ad study, as directed by the nmpa.

lecanemab selectively binds and eliminates soluble, toxic aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in ad. as such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. the clarity ad study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. in november 2022, the results of the clarity ad study were presented at , and simultaneously published in , peer-reviewed medical journals.

in the u.s., lecanemab was granted breakthrough therapy and fast track designations by the u.s. food and drug administration (fda) in june and december 2021, respectively. in july 2022, the fda accepted eisai’s bla for lecanemab under the accelerated approval pathway and granted it priority review. the prescription drug user fee act (pdufa) action date is january 6, 2023. eisai aims to file for traditional approval in the u.s. and for marketing authorization applications in japan and the europe by the end of eisai’s fy2022, which ends march 31, 2023.

eisai serves as the lead of lecanemab development and regulatory submissions globally with both eisai and biogen co-commercializing and co-promoting the product and eisai having final decision-making authority.

 

contacts
media contact:

eisai co., ltd.

public relations department

tel: 81-(0)3-3817-5120

 

 

investor contact:

eisai co., ltd.

investor relations department

tel: 81-(0)3-3817-5122

media contact:

biogen inc.

natacha gassenbach

1-857-777-6573

public.affairs@biogen.com

 

investor contact:

biogen inc.

mike hencke

1-781-464-2442

ir@biogen.com

tokyo and osaka, december 22, 2022  – astellas pharma inc. (tse: 4503, president and ceo: kenji yasukawa, “astellas”), eisai co., ltd. (tse: 4523, ceo: haruo naito, “eisai”), daiichi sankyo company, limited (tse: 4568, president : sunao manabe, “daiichi sankyo”) and takeda pharmaceutical company limited. (tse: 4502 / nyse:tak, president and ceo christophe weber, “takeda”) today announced that the four companies have agreed the collaboration to reduce environmental burden in the field of pharmaceutical packaging.

based on the agreement, the four companies will aim to promote the use of more environmentaly friendly packaging for pharmaceutical products by sharing knowledge on packaging technologies to reduce environmental burden, such as blister packs made of biomass-based plastic instead of petroleum-derived plastic, compact packaging, recycled packaging materials, and recyclable packaging materials.

astellas, eisai, daiichi sankyo, and takeda aim to ensure that society benefits from this collaboration to harmonize corporate activities with the global environment. in the future, the four companies expect to expand this collaboration beyond the four companies by calling on other companies in order to reduce further environmental burden.

 

■  initiatives for sustainability (environment) of each company

astellas has set “deepen our engagement in sustainability” as one of the strategic goals in its . the reduction of environmental burden is one of astellas’ priority themes within sustainability. for more information on specific initiatives, please visit .

eisai established the “eisai environmental management vision” this fiscal year, and in addition to climate change countermeasures aimed at achieving carbon neutrality by fiscal 2040, eisai has formed a medium- to long-term plan for environmental issues including efficient use of water and recycling of resources, and will work to further advance these efforts. to learn more about our environmental initiatives, please visit .

as a healthcare company with the purpose “to contribute to the enrichment of quality of life around the world,” daiichi sankyo considers global environmental conservation, which is the basis of life and livelihood, as a key management issue () and promotes environmental management. for more information on specific initiatives, please visit .

at takeda, “purpose-led sustainability” is about creating both business and societal value through its core business. takeda continues to reduce our operational carbon footprint and are now committed to achieving net-zero ghg emissions for scopes 1 and 2 before 2035 and for scope 3 before 2040. for more information, see our .

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has entered into an agreement to transfer the united states (u.s.) commercial rights for the anti-epileptic drug (aed) fycompa® (generic name: perampanel) ciii to catalyst pharmaceuticals, inc. (headquarters: the united states, “catalyst pharmaceuticals”), as well as to provide catalyst pharmaceuticals with an exclusive negotiation period for an asset in eisai’s epilepsy pipeline. eisai will maintain its rights to fycompa in countries and regions outside the u.s. and continue to contribute to patients with epilepsy. closing of the transaction is contingent on completion of review under antitrust laws in the u.s.

the agreement will provide the opportunity for eisai’s neuroscience team to focus on its long-term strategic priorities on the research, development, and commercialization of its alzheimer’s disease portfolio. eisai remains committed to drug discovery and research for anti-epileptogenesis through the modulation of neuroinflammation or lipid metabolism in glia cells, as well as the application of new technologies including spatial rna-sequence. research is a crucial aspect of eisai’s aim to gain a deeper understanding of human brain biology and technologies that may also ultimately lead to broader neuroscience discoveries.

in the u.s., fycompa was approved in 2012 and has been prescribed to more than 50,000 patients. catalyst pharmaceuticals is a company focused on developing therapies for rare neuromuscular as well as neurological disorders, and is increasing its presence in neurology in the u.s. the agreement is expected to maximize the patient value of fycompa in the u.s. due to its strong commitment to patients living with epilepsy.

under the terms of the agreement, eisai will receive a contractual up-front payment of $160 million (usd) upon closing of the transaction. in addition, milestone payments and royalties may be received in the future. eisai will continue to be responsible for the manufacture and supply of fycompa to global markets including the u.s. eisai’s u.s. subsidiary eisai inc. will provide transition services for a period to ensure patients continue to have access to this important medicine.

as a result of this transaction, eisai anticipates no changes to its consolidated financial forecast for the period ended march 31, 2023.

driven by our hhc concept, eisai strives to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas: neurology, oncology and global health. as an hhceco company, eisai aims to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities by creating solutions through building an ecosystem in collaboration with other industries.

 

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

 

media inquiries:

eisai inc. (u.s.)

christopher vancheri

551-305-0050

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that eisai and washington university school of medicine in st. louis have entered into a comprehensive research collaboration agreement aiming to create potential novel treatments for neurodegenerative disorders, including alzheimer’s disease (ad) and parkinson’s disease (pd).

washington university is world leading in research on prevention, diagnosis, biomarkers and treatment of neurodegenerative diseases. the two organizations have been collaborating in ad research. the phase ii/iii tau nexgen study conducted by the dominantly inherited alzheimer network trials unit (dian-tu), led by the university’s school of medicine, is exploring the safety, tolerability, biomarkers and cognitive efficacy of eisai’s anti-mtbr (microtubule binding region) tau antibody e2814 for the treatment of dominantly inherited alzheimer’s disease (diad). in this study, the anti-amyloid beta (aβ) protofibril antibody lecanemab (generic name, development code: ban2401) was selected as the background anti-amyloid agent.

the collaboration strategically combines washington university scientists’ expertise in the fundamental and clinical research in neurodegenerative diseases, such as dementia, with eisai’s extensive experience in drug discovery and development. using human biology, the aim is to create multiple novel therapeutic candidates as well as discover and identify biomarkers within the next five years. eisai will have the option rights to develop and commercialize any compounds and biomarkers that meet certain criteria in terms of research and development milestones. in the case that eisai chooses to exercise the options, eisai will pay washington university milestone payments and royalties on future sales of each licensed compounds.

dr. teiji kimura, ph.d., academia and industry alliance officer, deep human biology learning (dhbl) office of eisai, commented, “patients living with neurodegenerative diseases, including alzheimer’s disease and parkinson’s disease, struggle with critical unmet medical needs, which is the reason neurology is a key therapeutic area for eisai. by collaborating with world-leading research institutions such as washington university in st. louis, eisai is working to fulfill our human health care mission and provide potential new and targeted disease-modifying therapies with the ultimate goal of achieving a world free of neurodegenerative disease.”

 

media inquiries:

public relations department, eisai co., ltd.

81-(0)3-3817-5120

eisai inc (u.s.)

libby holman 201-753-1945

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that new study results on its in-house discovered and developed anticancer agent eribulin mesylate (halaven®, “eribulin”) will be presented during the 2022 san antonio breast cancer symposium (sabcs), which is taking place virtually and in-person in san antonio, texas from december 6-10.

 

eisai will present five eribulin-related abstracts, including a post hoc subgroup analysis from two pivotal phase 3 studies (embrace and study 301), as well as:

–    real world use of eribulin following treatment with a p13k inhibitor, mostly in people with hormone receptor (hr)-positive/her2-negative metastatic breast cancer.

–    preclinical data exploring a liposomal formulation of eribulin, in a phase 1 expansion cohort for breast cancer, versus eribulin at the same dose, in patient-derived breast cancer xenografts.

 

“we continue to relentlessly pursue research that provides useful insights for people living with breast cancer,” said dr. takashi owa, chief scientific officer, senior vice president, eisai co., ltd. “a big part of this commitment is the ongoing sharing of our preclinical and clinical data with eribulin.”

 

this release discusses investigational compounds and investigational uses for fda-approved products. it is not intended to convey conclusions about efficacy and safety. there is no guarantee that any investigational compounds or investigational uses of fda-approved products will successfully complete clinical development or gain fda approval.

 

eisai presentations at the 2022 sabcs are as follows:

tokyo and cambridge, eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that the results from eisai’s large global phase 3 confirmatory clarity ad clinical study of lecanemab (development code: ban2401), an investigational anti-amyloid beta (aβ) protofibril antibody for the treatment of mild cognitive impairment (mci) due to alzheimer’s disease (ad) and mild ad (collectively known as early ad) with confirmed presence of amyloid pathology in the brain, were presented at the 2022 clinical trials on alzheimer’s disease (ctad) conference, in san francisco, california and virtually.

 

summary of presentations in the scientific session featuring lecanemab at ctad

 

design of clarity ad study

eisai’s clarity ad was a global confirmatory phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early ad (lecanemab group: 898 placebo group: 897) at 235 sites in north america, europe, and asia. the participants were randomized 1:1 to receive either placebo or lecanemab 10-mg/kg iv biweekly, and the randomization was stratified according to clinical subgroup (mci due to ad or mild ad), presence or absence of concomitant approved ad symptomatic medication at baseline (e.g., acetylcholinesterase inhibitors, memantine, or both), apoe4 status and geographical region. eligibility criteria allowed patients with a broad range of comorbidities/comedications, including but not limited to hypertension, diabetes, heart disease, obesity, renal disease and anti-coagulants. as a result of eisai’s recruitment strategy of diversity in the clarity ad study, 4.5% and 22.5% of the randomized participants in the u.s. were black and hispanic, respectively.

 

the primary endpoint was change from baseline at 18 months in the cdr-sb1 (clinical dementia rating sum of boxes), the global cognitive and functional scale, and key secondary endpoints were the change from baseline at 18 months in amyloid positron emission tomography (pet) using centiloids, ad assessment scale – cognitive subscale 14 (adas-cog142), ad composite score (adcoms3) and ad cooperative study-activities of daily living scale for mild cognitive impairment (adcs mci-adl4). in addition, longitudinal changes in brain tau pathology as measured by tau pet (n=257) and cerebrospinal fluid (csf) biomarkers of ad pathology (n=281) were evaluated in optional sub-studies.

 

efficacy results of clarity ad

mean change of cdr-sb from baseline at 18 months as the primary endpoint was 1.21 and 1.66 for lecanemab and placebo groups, respectively. lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale, compared with placebo at 18 months by -0.45 (95% confidence interval (ci): -0.67, -0.23; p=0.00005), representing a 27% slowing of decline. starting as early as six months (difference: -0.17 [95% ci: -0.29, -0.05]; p<0.01), and increasing in absolute difference over time across all time points every 3 months, the treatment showed highly statistically significant changes in cdr-sb from baseline compared to placebo (all p-values are less than 0.01) (figure 1).

 

all key secondary endpoints also showed highly statistically significant results compared with placebo (p<0.001). in the amyloid pet sub-study, treatment with lecanemab showed statistically significant reduction in amyloid plaque burden at all timepoints starting at 3 months. mean change in centiloids at 18 months was -55.5 and 3.6 for lecanemab and placebo groups, respectively (mean difference: -59.1 [95%ci: -62.6, -55.6]; p<0.00001). lecanemab slowed decline of cognitive function by 26% on adas-cog14 at 18 months (mean difference: -1.44 [95%ci: -2.27, -0.61]; p=0.00065). in the adcoms assessment, lecanemab slowed disease progression by 24% at 18 months (mean difference: -0.050 [95% ci: -0.074,  -0.027; p=0.00002]). lecanemab slowed decline of activities of daily living by 37% on adcs mci-adl at 18 months (mean difference: 2.016 [95%ci: 1.208, 2.823]; p<0.00001). in addition, the primary stratified analysis showed consistent results in cdr-sb, adas-cog14 and adcs mci-adl at 18 months of treatment with lecanemab in all subgroups of disease stage (mci due to ad or mild ad), apoe4 status (non-carriers, carriers), presence or absence of concomitant approved ad symptomatic medication, and region (north america, asia, europe).

 

figure1. cdr-sb as primary endpoint change (18 months)

 

safety results of clarity ad

the most common adverse events (>10%) in the lecanemab group were infusion reactions (lecanemab: 26.4%; placebo: 7.4%), aria-h (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis; lecanemab: 17.3%; placebo: 9.0%), aria-e (edema/effusion; lecanemab: 12.6%; placebo: 1.7%), headache (lecanemab: 11.1%; placebo: 8.1%), and fall (lecanemab: 10.4%; placebo: 9.6%). infusion reactions were largely mild-to-moderate (grade 1-2: 96%) and occurred on the first dose (75%).

 

during the study period, deaths occurred in 0.7% and 0.8% of participants in the lecanemab and placebo groups, respectively and no deaths were related to lecanemab or occurred with amyloid-related imaging abnormalities (aria) in 18-month double-blind study period. serious adverse events were experienced by 14.0% of participants in the lecanemab group and 11.3% of participants in the placebo group. treatment-emergent adverse events occurred in 88.9% and 81.9% of participants in the lecanemab and placebo groups, respectively. treatment-emergent adverse events leading to drug withdrawal occurred in 6.9% and 2.9% of participants in the lecanemab and placebo groups, respectively.

 

overall, lecanemab’s aria incidence profile was within expectations based on the phase 2 trial results. aria-e events were largely mild-to-moderate radiographically (91% of those who had aria-e), asymptomatic (78% of those who had aria-e), occurred within the first 3 months of treatment (71% of those who had aria-e) and resolved within 4 months of detection (81% of those who had aria-e). among the 2.8% of lecanemab-treated subjects with symptomatic aria-e, the most commonly reported symptoms were headache, visual disturbance, and confusion. the incidence of symptomatic aria-h was 0.7% in the lecanemab group and 0.2% in the placebo group. no imbalance was observed in isolated aria-h (i.e., aria-h in participants who did not also experience aria-e) between lecanemab (8.9%) and placebo (7.8%). aria-e and aria-h were less common in apoe4 non-carriers versus carriers, with higher frequency in apoe4 homozygous carriers vs apoe4 heterozygous carriers. in the core study and subsequent open-label extension study, rates of deaths with concurrent cerebral macrohemorrhage were 0.1% in both the placebo group (1/897) and the lecanemab group (2/1608). the two cases on lecanemab occurred in the open-label extension study. both cases had significant comorbidities and risk factors including anticoagulation contributing to macrohemorrhage or death. therefore, it is eisai’s assessment that the deaths cannot be attributed to lecanemab.

 

imaging, plasma, and csf biomarkers assessments of clarity ad

biomarkers assessments on amyloid, tau and neurodegeneration with lecanemab administration were conducted using imaging, plasma and csf. amyloid biomarkers showed early and sustained amyloid reversal effects in csf and plasma aβ 42/40 ratio with lecanemab treatment. mean amyloid pet was 22.99 centiloids at 18 months of lecanemab treatment which was below threshold for amyloid positivity of 30 centiloids. tau biomarkers showed that removing amyloid improved csf and plasma p-tau (p-tau181), downstream of amyloid in the ad pathology pathway. tau pet analysis showed that lecanemab treatment slowed tau accumulation in the temporal lobe as well as improved total tau (t-tau) in compared to the placebo. as for biomarkers of neurodegeneration, lecanemab improved glial fibrillary acidic protein (gfap) in plasma, a marker of astrocyte activation, and neurogranin in csf, a marker of synaptic dysfunction, improved to normal levels by treatment, while there was no significant difference in neurofilament light chains in csf or plasma between lecanemab and placebo.

 

clarity ad results in context

ad is a progressive neurological disorder that severely impacts people living with the condition and their loved ones. with the increased global aging population, ad has become a critical issue for society and healthcare systems. new therapeutic agents that act on the disease pathology are needed. the treatment goals for early ad are to have sustained effects on cognitive function, activities of daily living and psychiatric symptoms, to maintain independence longer by slowing progression of the disease and to improve or maintain quality of life.

 

in eisai’s confirmatory clarity ad study, lecanemab demonstrated consistency of results across scales of cognition and function and subgroups (race, ethnicity, comorbidities). lecanemab treatment showed 31% lower risk of converting to next stage of disease by global cdr assessment (hazard ratio: 0.69). a slope analysis using cdr-sb based on observed data and extrapolation to 30 months showed that lecanemab takes 25.5 months to reach same level as placebo at 18 months, indicating a 7.5 month slowing of progression. modeling simulations based on the phase 2 trial data suggest that lecanemab may slow the rate of disease progression by 2.5-3.1 years and has the potential to help people remain in the earlier stages of ad for a longer period of time. in addition, it was shown to maintain the health-related quality of life and reduce the burden on caregivers (23-56% reduction in score worsening). the convergence of evidence across cognition and function, disease progression, health related quality of life, and caregiver burden demonstrate that lecanemab treatment may provide meaningful benefits to patients, their care partners, physicians and society.

 

eisai is hosting a live webcast of the scientific session featuring the lecanemab presentations, which can be viewed live on . the content will be available on demand afterward.

 

eisai serves as the lead of lecanemab development and regulatory submissions globally with both eisai and biogen co-commercializing and co-promoting the product and eisai having final decision-making authority.

 

this release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. there is no guarantee that such an investigational agent will successfully gain health authority approval.

 

1 cdr-sb is a numeric scale used to quantify the various severity of symptoms of dementia. based on interviews of people living with ad and family/caregivers, qualified healthcare professionals assess cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. the total score of the six areas is the score of cdr-sb, and cdr-sb is also used as an appropriate item for evaluating the effectiveness of therapeutic drugs targeting the early stages of ad.

2 adas-cog is the most common cognitive assessment instrument used in ad clinical trials all over the world. adas-cog14 consists of 14 competencies: word recall, commands, constructional praxis, object and finger naming, ideational praxis, orientation, word recognition, remembering word recognition instructions, comprehension of spoken language, word finding difficulty, spoken language ability, delayed word recall, number cancellation, and maze task. adas-cog has been used in clinical trials for earlier stages of ad including mci.

3 developed by eisai, adcoms combines items from the adas-cog scale for assessing cognitive functions, mmse and the cdr scale for evaluating the severity of dementia to enable highly sensitive detection of changes in clinical functions of early ad symptoms and changes in memory

4 adcs mci-adl assesses the competence of patients with mci in activities of daily living (adls), based on 24 questions to the patient’s partner about actual recent activities of daily living.

 

eisai co., ltd. (headquarters: toyoko, ceo: haruo naito, “eisai”) will present the efficacy, safety and biomarker findings from the company’s phase 3 confirmatory clarity ad clinical trial for lecanemab (development code: ban2401), an investigational anti-amyloid beta (aβ) protofibril antibody for the potential treatment of mild cognitive impairment (mci) due to alzheimer’s disease (ad) and mild ad (collectively known as early ad) with confirmed presence of amyloid pathology in the brain, at the 15th clinical trials on alzheimer’s disease (ctad) conference. at the meeting, which will be held in san francisco, ca and virtually from november 29 to december 2, eisai and esteemed faculty will present the full data in a scientific session on the first day of the meeting (november 29 at 4:50 p.m. pt). additionally, other important research from the lecanemab clinical development program and eisai’s ad pipeline, including the company’s investigational anti-microtubule binding region (mtbr) tau antibody (e2814), will be presented in four oral and ten poster presentations.

 

topline results from clarity ad were announced in late september and showed that lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results, and the profile of amyloid-related imaging abnormalities (aria) incidence was within expectations.

 

key eisai lecanemab ctad presentations

  • clarity ad: full results from the phase 3 confirmatory clarity ad clinical trial of lecanemab in patients with early ad will be presented in a scientific session on november 29 at 4:50 p.m. pt. eisai will host a live webcast of presentations in the session and can be viewed live on the of the eisai co., ltd. website.
  • aβ protofibrils binding properties: research studying the characterization of aβ protofibrils and the unique binding properties and mechanisms of aβ clearance of lecanemab (poster #p029)
  • ahead 3-45 study:
    an evaluation of tau pet screening data from the phase 3 ahead 3-45 study of lecanemab for associations with plasma p-tau217 and cognitive testing (late breaker oral #lb1)
    a study exploring increased accuracy of amyloid pet prediction in preclinical ad using plasma levels for abeta42/40 and p-tau217 ratios from the phase 3 screening data from the ahead 3-45 study (late breaker oral #lb2)
“based on the clarity ad results, the investigational anti-amyloid beta protofibril antibody lecanemab has the potential to make a clinically meaningful difference for people living with the early stages of alzheimer’s disease and their families by slowing cognitive and functional decline,” said lynn kramer, m.d., chief clinical officer, alzheimer’s disease and brain health at eisai co., ltd. “eisai is excited to share the results of the company’s confirmatory phase 3 clarity ad clinical study at ctad and present important data exploring lecanemab’s potential efficacy, safety and use in a variety of early ad patient sub-populations.”

 

eisai aims to file for traditional approval in the u.s. and for marketing authorization applications in japan and europe by the end of eisai’s fy2022, which ends march 31, 2023. in july 2022, the u.s. food and drug administration (fda) accepted eisai’s biologics license application (bla) for lecanemab under the accelerated approval pathway and granted it priority review. the prescription drug user fee act (pdufa) action date is january 6, 2023. the fda has agreed that the results of clarity ad can serve as the confirmatory study to verify the clinical benefit of lecanemab. in an effort to secure traditional fda approval for lecanemab as soon as possible, eisai submitted the bla through the fda’s accelerated approval pathway so that the agency could complete its review of all lecanemab data with the exception of the data from the confirmatory clarity ad study. in march 2022, eisai began submitting application data, with the exception of clarity ad data, to japan’s pharmaceuticals and medical devices agency (pmda) under the prior assessment consultation system, with the aim of obtaining early approval for lecanemab so that people living with early ad may have access to the therapy as soon as possible.

 

ctad 2022 presentations relating to eisai’s key compounds, research and collaborations

scientific session: clarity ad: a phase 3 placebo-controlled, double-blind, parallel-group, 18-month study evaluating lecanemab in early alzheimer’s disease
tues, nov 29, 4:50 – 6:05 p.m. pt
chairman: takeshi iwatsubo, university of tokyo
clarity ad: clinical trial background and study design overview

michael irizarry

eisai inc.

lecanemab for the treatment of early alzheimer’s disease: topline efficacy results from clarity ad

christopher van dyck

yale school of medicine

safety profile of lecanemab in early alzheimer’s disease

marwan sabbagh

barrow neurological institute

imaging, plasma and csf biomarkers assessments from clarity ad randall bateman
washington university
context of clarity ad results sharon cohen
toronto memory program
panel discussion / q&a

oral presentations

asset in development, session, time (pacific time) presentation title, presenter/authors

lecanemab
session: late breaking oral communications: #lb1
wed, nov 30
session time: 10:30 – 11:00 a.m.
presentation time: 10:30 – 10:45 a.m.

tau pet associated with plasma p-tau217 and cognitive testing in preclinical ad: screening data from the ahead study a3 and a45 trials
presenter: k johnson

authors: k johnson, et al

lecanemab
session: late breaking oral communications: #lb2
wed, nov 30
session time: 10:30 – 11:00 a.m.

presentation time: 10:45 – 11:00 a.m.

plasma levels of abeta42/40 and p-tau217 ratios increase accuracy of amyloid pet prediction in preclinical ad
presenter: r rissman

authors: r rissman, et al

e2814
session: late breaking oral communications: #lb4
wed, nov 30
session time: 3:00 – 3:45 p.m.
presentation time: 3:15 p.m. – 3:30 p.m.

csf mtbr-tau243 is a non-amyloid specific biomarker of neurofibrillary tangles of alzheimer’s disease
presenter: k horie

authors: k horie, et al

e2027
session: oral communications:
#oc2
wed, nov 30
session time: 11:00 a.m. – 12:15 p.m.

presentation time: 11:15 – 11:30 a.m.

results of a phase 2/3 placebo-controlled, double-blind, parallel-group, randomized study to evaluate the efficacy and safety of 12 week treatment with the phosphodiesterase 9 (pde9) inhibitor irsenontrine (e2027) in subjects with dementia with lewy bodies
presenter: m irizarry

authors: m irizarry, et al

 

poster presentations

asset in development, session, time (pacific time) presentation title, authors

lecanemab
session: clinical trials methodology: #p012
tues, nov 29, 4:00 p.m. –
wed, nov 30, 6:00 p.m.

development and feasibility of a data-driven approach to preclinical alzheimer’s disease clinical trial recruitment through centralized pre-screening data collection

authors: d kirn, et al

lecanemab
session: new therapies and clinical trials: #p029
tues, nov 29, 4:00 p.m. –

wed, nov 30, 6:00 p.m.

characterization of amyloid-beta protofibrils in alzheimer’s disease brain and the unique binding properties of lecanemab

authors: l lannfelt, et al

e2027
session: clinical trials results: #p048
tues, nov 29, 4:00 p.m. –

wed, nov 30, 6:00 p.m.

the effects of the novel phosphodiesterase 9 (pde9) inhibitor e2027 (irsenontrine) on csf cgmp, additional csf and plasma biomarkers, and clinical outcomes in amyloid positive and amyloid negative patients with dementia with lewy bodies and parkinson’s disease dementia

authors: p sachdev, et al

general ad
session: clinical trials results: #p037
tues, nov 29, 4:00 p.m. –

wed, nov 30, 6:00 p.m.

planning the next generation of alzheimer’s disease clinical trials using diverse patient-level database from the critical path for alzheimer’s disease (cpad) consortium

authors: s sivakumaran, et al

general ad
session: clinical trials results: #p038
tues, nov 29, 4:00 p.m. –
wed, nov 30, 6:00 p.m.

critical path for alzheimer’s disease (cpad) consortium: accelerating and de-risking therapeutic development in ad by building regulatory decision-making tools
authors: s sivakumaran, et al

general ad
session: clinical trials biomarkers including plasma: #lp66
thu, dec 1, 8:00 a.m. – 6:00 p.m.

baseline plasma ptau181 improves prediction of cognitive decline in amyloid positive subjects with mild cognitive impairment
authors: v devanarayan, et al

general ad
session: epidemiology and clinical trials: #p176
fri, dec 2, 8:00 a.m. – 5:00 p.m.

identification of medical conditions as risk factors for mild cognitive impairment: a us claims database study
authors: g li, et al

general ad
session: epidemiology and clinical trials: #p184
fri, dec 2, 8:00 a.m. – 5:00 p.m.

prevalence estimations for the alzheimer’s disease continuum in the us health and retirement study
authors: a abbas tahami monfared, et al

general ad
session: cognitive and functional endpoints:
#p139 (virtual only)
thu, dec 1, 8:00 a.m. – 6:00 p.m.

dementia conversion rate differences between patients with high- and low-risk amnestic mild cognitive impairment in the real-world: a prospective, multicenter, observational study
authors: h jang, et al

 

sysmex poster presentation

asset in development, session, time (pacific time) presentation title, authors

general ad
session: clinical trials biomarkers including plasma: #lp84a

thu, dec 1, 8:00 a.m. – 6:00 p.m.

three group classification of participants based on fully automated plasma β-amyloid measurements to achieve high positive and negative predictive values

authors: k yamashita, et al

 

eisai serves as the lead of lecanemab development and regulatory submissions globally, with both eisai and biogen co-commercializing and co-promoting the product and eisai having final decision-making authority.

 

this release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. there is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

 

media inquiries:

eisai co., ltd.

public relations department,

81-(0)3-3817-5120

 

eisai inc. (u.s.)

libby holman

1-201-753-1945

 

eisai europe, ltd. (europe, australia, new zealand and russia)

emea communications department

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