Biogen Inc. (NASDAQ: BIIB) saw no significant change in its stock price during Thursday’s after-hours trading, following a minor dip of 0.31% to $284.99 in regular trading.
In a late announcement yesterday, the U.S. Food and Drug Administration (FDA) revealed that it has granted traditional approval to Eisai Inc.’s Leqembi (lecanemab) for the treatment of Alzheimer’s Disease (AD) in adult patients. This decision comes after a confirmatory trial that confirmed the clinical benefits of the drug.
Eisai and Biogen have been working together since 2014 on the development and commercialization of treatments for Alzheimer’s. Eisai has been leading the development and regulatory submissions of Leqembi worldwide, while both companies will collaborate on its marketing and promotion, with Eisai having the final decision-making authority.
In an official press release on Thursday, the FDA stated that Leqembi is the first amyloid beta-directed antibody to transition from accelerated approval to traditional approval for Alzheimer’s treatment. This drug tackles one of the key features of the disease by reducing amyloid plaques in the brain. The efficacy of Leqembi was evaluated in a Phase 3 trial involving 1,795 patients.
The FDA also highlighted some common side effects of Leqembi, including headache, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA). It cautioned against the use of Leqembi in patients with hypersensitivity to its components and warned of the risk of intracerebral hemorrhage when combined with anticoagulants.
Furthermore, the FDA recommended initiating Leqembi treatment in patients with mild cognitive impairment or mild dementia stages of Alzheimer’s.
According to data from Benzinga Pro, BIIB’s highest price in the past 52 weeks was $319.76, while its lowest was $193.65.