Eisai’s Lecanemab BLA Filing A Key Step For Ailing Biogen
Completed Rolling Submission Beats Lilly’s Donanemab To US FDA
Executive Summary
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.
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Eisai/Biogen Maintain Lead Over Lilly In New Race To Alzheimer’s Approval
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.
Could Patient Stratification Help Lilly Finally Unlock An Alzheimer’s Breakthrough?
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.
Failure Of Roche’s Nine-Year Alzheimer’s Prevention Study Disappointing, But No Surprise
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.