Alzheimer’s drug heads to FDA for approval
Biogen has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of aducanumab, an investigational treatment for Alzheimer’s disease, according to a company press release.
The submission included data from the Phase 3 EMERGE and ENGAGE studies, as well as the Phase 1b PRIME study.
In March 2019, the EMERGE and ENGAGE trials were discontinued after a futility analysis indicated that the studies were unlikely to meet the primary endpoint. In October 2019, the company said a review of data showed that aducanumab reduced cognitive decline in EMERGE.
The FDA now has up to 60 days to decide whether to accept the application for review.
For more information, click here.