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

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) decision not to cover amyloid-targeting therapies cleared through the FDA’s...