Alzheimer's Early Approval? Skepticism Over Biogen/Eisai's BAN2401 Data Clouds Chances
18-month Phase II data on amyloid-targeting antibody BAN2401, presented at AAIC, raised more questions than they answered – and seemed to take the wind out of the sails for an early regulatory filing.
You may also be interested in...
Biogen and Eisai still have multiple programs testing amyloid-targeting therapies in the treatment of Alzheimer's disease, but pressure for Biogen to focus its efforts elsewhere are mounting after the partners discontinued Phase III studies for aducanumab.
As part of broader efforts to pursue novel approaches to common neurological disorders, Eisai uses iPSC-derived cells to help identify potential new drug therapies for Parkinson's.
The company told its Q2 call it plans to talk to regulators about a filing strategy for the amyloid-targeting antibody based on Phase II data. Spinraza had a strong quarter, but Biogen’s SMA gene therapy is on clinical hold.