BIIB - Eisai Biogen file for EU marketing authorization of Alzheimer's drug

2024-01-11 05:46:14 ET

Biogen ( NASDAQ: BIIB ) and its Japanese partner Eisai ( OTCPK:ESALF ) have filed a marketing authorization application for their breakthrough Alzheimer's therapy, called Leqembi (lecanemab), in the EU.

The application to the European Medicines Agency (EMA) is based on the results of the Phase 3 Clarity study and the Phase 2b clinical study, which demonstrated that lecanemab treatment showed a reduction of clinical decline in early Alzheimer's disease.

Eisai ( OTCPK:ESALF ) expects the European Commission's decision for the MAA of lecanemab in the first quarter of FY2024 ending June 30, 2024.

Earlier this week, Leqembi, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody, received approval in China as a treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease.

In July 2023, the U.S. FDA fully approved Leqembi for adults with Alzheimer's disease, and subsequently, the companies launched the product in the U.S. for $26.5K. The drug later rolled out in Japan for about ¥2.98M ($20.4K) per patient per year.

Eisai ( OTCPK:ESALF ) serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen ( BIIB ) co-commercializing and co-promoting the product and Eisai having final decision-making authority.

BioArctic, a Swedish research-based biopharma company, has right to commercialize lecanemab in the Nordic under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai.

In conjunction with the regulatory filing to EMA announced today, and the subsequent acceptance of the file by EMA, BioArctic is entitled to a milestone of MEUR 5.

More on Biogen, Eisai, etc.

• Biogen Inc. (BIIB) JPMorgan 42nd Annual Healthcare Conference (Transcript)
• Biogen: LEQEMBI's $10 Billion Potential
• Biogen Inc. (BIIB) Evercore ISI 6th Annual HealthCONx Conference (Transcript)
• Biogen, Eisai win China approval for Alzheimer's drug
• Europe revokes approvals for generics of Biogen's multiple sclerosis drug Tecfidera

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