FDA expediting two more anti-amyloid therapies for Alzheimer’s
Aducanumab decision already opening the door to approvals on Phase II data
Aducanumab decision already opening the door to approvals on Phase II data .
After its accelerated approval of Biogen’s aducanumab, FDA is moving quickly to expedite development of two more anti-amyloid mAbs, with Lilly’s donanemab looking like it could be the first in the indication to receive approval based on Phase II data.
On Wednesday, FDA granted breakthrough designation to donanemab from Eli Lilly and Co. (NYSE:LLY) and lecanemab (BAN2401) from partners Eisai Co. Ltd. (Tokyo:4523) and Biogen Inc. (NASDAQ:BIIB). The designations were based on Phase II results demonstrating both therapies reduce amyloid plaques in the brain and may have clinical benefit. Both compounds are