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Eisai’s Lecanemab BLA Filing A Key Step For Ailing Biogen

Completed Rolling Submission Beats Lilly’s Donanemab To US FDA

 
• By Mandy Jackson

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. 

Retro alarm clock at 5 minutes to 12 o'clock
The clock is ticking in the competition to bring the next anti-amyloid antibody to market • Source: Shutterstock

Biogen, Inc.’s Aduhelm (aducanumab) was one of the most closely watched and worst-performing drug launches in recent memory. But as the company winds down commercialization of the anti-amyloid antibody, partner Eisai Co., Ltd. has completed a rolling biologic license application (BLA) submission to the US Food and Drug Administration for a second anti-amyloid antibody, offering hope for another potential shot at a blockbuster product for the disease.

Eisai and Biogen are seeking accelerated approval for lecanemab, despite the recent US Centers for Medicare and Medicaid Services (CMS)...

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