ADUHELM received accelerated approval from the U.S. Food and Drug Administration in June 2021. The Phase 4 post-marketing confirmatory ENVISION study was a requirement of FDA accelerated approval of ADUHELM.
Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen commercializing and co-promoting the product and Eisai having final decision-making authority.
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BIIB080 is licensed from Ionis.
About Biogen
Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, two co-developed treatments to address a defining pathology of Alzheimer’s disease, the first treatment to target a genetic form of ALS, the first oral treatment approved for postpartum depression, and the first approved treatment for Friedreich’s ataxia. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.
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