Fast Track designation for Biogen's aducanumab

FDA granted Fast Track designation to Biogen Inc. (NASDAQ:BIIB) for aducanumab to treat early Alzheimer's disease. The human recombinant anti-beta amyloid mAb is in two Phase III trials for the indication.

In a study published online Wednesday in Nature, aducanumab reduced beta amyloid plaques and slowed clinical progression on the Clinical Dementia Rating-Sum of Boxes score in the Phase Ib PRIME trial. The company first reported data from the study last year (see BioCentury Extra, March 20, 2015). ...