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Alzheimer's Early Approval? Skepticism Over Biogen/Eisai's BAN2401 Data Clouds Chances

 
• By Mandy Jackson and Mary Jo Laffler

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.

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While Biogen Inc. executives teased the possibility of an early regulatory filing for the Alzheimer's candidate BAN2401 the day before additional data were presented, the Phase II data released July 25 at the Alzheimer’s Association International Conference (AAIC) raised enough concerns that an accelerated filing appears risky. 

Detailed results from the 856-patient, Phase II Study 201 at 18 months were presented on July 25 at the AAIC...

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