Biogen up on FDA acceptance of aducanumab Alzheimer’s application

Under Priority Review status, the FDA has accepted Biogen’s (NASDAQ:BIIB) marketing application seeking approval of aducanumab for the treatment of Alzheimer’s disease (AD).

The agency’s action date is March 7, 2021, although it may act earlier.

If approved, it will be the first authorized medicine to reduce the clinical decline of AD and the first to show that removing amyloid beta resulted in improved clinical outcomes.

The company is optimistic for an FDA nod based on the totality of the data. Results from two Phase 3 studies were uneven. In the EMERGE trial. the high-dose arm met the primary and two secondary endpoints at week 78 but the low-dose arm missed all endpoints. In the ENGAGE study, both the high-dose and low-dose arms failed to achieve the primary or secondary endpoints.

https://seekingalpha.com/news/3602799-biogen-up-12-on-fda-acceptance-of-aducanumab-application