Eisai/Biogen Maintain Lead Over Lilly In New Race To Alzheimer’s Approval

Eisai Co., Ltd. and Biogen, Inc. remain at least a few months ahead of Eli Lilly and Company in the race to win accelerated approval and rapidly bring a second amyloid-targeting antibody to market in the US. Eisai and Biogen announced on 5 July that the Food and Drug Administration accepted their biologics license application (BLA) for lecanemab and granted priority review, setting a 6 January action date for the early Alzheimer’s disease therapy.

If approved, lecanemab (BAN2401) would not be the first anti-amyloid antibody that the partners have brought to market with an accelerated endorsement from the FDA, but there are some differences that could make it more successful than the first, Aduhelm (aducanumab). Unlike aducanumab, lecanemab has the potential to gain full approval within a year of the initial decision