BIIB - Biogen Eisai win China approval for Alzheimer's drug

2024-01-09 05:30:25 ET

Biogen ( NASDAQ: BIIB ) and its Japanese partner Eisai ( OTCPK:ESALF ) announced on Tuesday market approval for their breakthrough Alzheimer's therapy, called Leqembi, in China.

Leqembi (lecanemab), a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody, has been approved in China as a treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease.

China becomes the third country to approve the drug following the U.S. and Japan. 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.

The approval in China is based on the large global Phase III Clarity AD study, where Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results.

Preparations for launch within the second quarter of Eisai's ( OTCPK:ESALF ) FY 2024 (July 1 – September 30, 2024) are underway.

More on Biogen, Eisai, etc.

• Biogen Inc. (BIIB) J.P. Morgan 42nd Annual Healthcare Conference (Transcript)
• Biogen: LEQEMBI's $10 Billion Potential
• Biogen Inc. (BIIB) Evercore ISI 6th Annual HealthCONx Conference (Transcript)
• Europe revokes approvals for generics of Biogen's multiple sclerosis drug Tecfidera
• EU regulators issue positive opinion for Biogen Friedreich's Ataxia drug

For further details see: