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confirmatory phase 3 clarity ad data to be evaluated by fda in determining whether to convert accelerated approval of leqembi to a traditional approval

priority review accelerates fda review time with a prescription drug user fee act (pdufa) target action on july 6, 2023

tokyo and cambridge, mass., march 6, 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 the u.s. food and drug administration (fda) has accepted eisai’s supplemental biologics license application (sbla) for leqembi™ (lecanemab-irmb) 100 mg/ml injection for intravenous use, supporting the conversion of the accelerated approval of leqembi to a traditional approval. the leqembi application has been granted priority review, with a prescription drug user fee act (pdufa) action date of july 6, 2023. the fda is currently planning to hold an advisory committee to discuss this application but has not yet publicly announced the date of the meeting.

leqembi is a humanized immunoglobulin gamma 1 (igg1) monoclonal antibody directed against aggregated soluble (protofibrils*) and insoluble forms of amyloid beta (aβ), approved under the accelerated approval pathway for the treatment of alzheimer’s disease (ad) on january 6, 2023. treatment with leqembi should only be initiated in patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of aβ pathology. on the same day that leqembi received its accelerated approval, eisai submitted the sbla to the fda for approval under the traditional pathway.

the sbla is based on the findings from eisai’s recently published large, global confirmatory phase 3 clinical trial, clarity ad. leqembi met the primary endpoint and all key secondary endpoints with highly statistically significant results. in november 2022, results of the clarity ad study were presented at the clinical trials on alzheimer’s disease (ctad) conference and simultaneously published in the peer-reviewed medical journal, the new england journal of medicine.

leqembi was approved under accelerated approval in the u.s. and  was launched in the u.s. on january 18, 2023. the accelerated approval was based on phase 2 data that demonstrated that leqembi reduced the accumulation of aβ plaque in the brain, a defining feature of ad, and its continued approval may be contingent upon verification of leqembi’s clinical benefit in a confirmatory trial. the fda has determined that the results of clarity ad can serve as the confirmatory study to verify the clinical benefit of lecanemab.

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

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.

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 lecanemab–irmb (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 amyloid–related 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 infusion–related 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)3–3817–5120

eisai inc. (u.s.)
libby holman
1–201–753–1945
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
1–857–777–6573
public.affairs@biogen.com

investor contacts:
eisai co., ltd.
investor relations department
tel: 81 (0) 3–3817–5122

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 .