Biogen scores a priority review for its Alzheimer's drug aducanumab, moving one giant leap forward in its controversial quest
Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.
The PDUFA date is March 7, 2021.
Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.
That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.