Eisai’s Lecanemab BLA Filing A Key Step For Ailing Biogen
Completed Rolling Submission Beats Lilly’s Donanemab To US FDA
Aduhelm commercialization was a bust, so Biogen’s next big hope for a potential blockbuster Alzheimer’s therapy is partner Eisai’s amyloid protofibril-targeting antibody lecanemab.
You may also be interested in...
The US FDA accepted an application for accelerated approval and set a 6 January action date, giving lecanemab ample time to reach the market ahead of Lilly’s competing anti-amyloid antibody donanemab.
Lilly believes its approach can help identify the Alzheimer’s patients who would benefit most from a beta amyloid clearing therapy – but skepticism about the mechanism itself remains widespread.
The ambitious prevention study in people with a nearly 100% chance of developing Alzheimer’s disease has failed, and attention will now switch to trial readouts for the next generation of beta-amyloid targeting candidates.