Daily Archives: August 20, 2020
Biogen’s aducanumab is inching closer to an FDA decision. The Big Biotech, along with partner Eisai, announced that the FDA accepted its regulatory submission for aducanumab, its once-failed Alzheimer’s drug—with priority review to boot. The agency expects to decide the fate of the treatment by March 7. Along the way, it will hold an advisory committee meeting. It has not set a date for the meeting, but Jefferies analyst Michael Yee expects it sometime in the first quarter of 2021.
“The FDA’s acceptance of the aducanumab BLA with Priority Review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer’s disease,” said Michel Vounatsos, Chief Executive Officer at Biogen.
How the FDA rules on aducanumab will show how far the FDA and its commissioner, Stephen Hahn, M.D., are willing to diverge from its established approval standards. Under U.S. law, companies need to show “substantial” evidence of effectiveness to win approval.