Under priority review status, the FDA has accepted (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 drug authorized to reduce clinical decline in AD and the first to show that elimination of beta amyloid has improved clinical outcomes.
The company is optimistic for a nod from the FDA based on the totality of the data. The results of two phase 3 studies were mixed. In the EMERGE test. the high dose arm met both primary and secondary endpoints at week 78, but the low dose arm missed all endpoints. In the ENGAGE study, the high dose and low dose arms failed to meet primary or secondary endpoints.
Find out how Biogen is performing against similar stocks through 2020.