Agency thinks Biogen’s sucessful Phase III study supports approval, but given the negative outcome of another trial and disease-modifying mechansim of action, an advisory committee endorsement could go a long way in assuring the public the Alzheimer's drug actually works; the panel will comprise 11 voting members, four of whom were added as temporary members for their expertise in neurology, biostatistics and patient advocacy.
The US Food and Drug Administration’s positive view of Biogen, Inc.’s aducanumab suggests the agency may be primed to approve the Alzheimer’s drug with or without the backing of its external experts.
However, given thediscordant data from two Phase III trials that were prematurely terminated, and the agency's work with Biogen in...