Aducanumab from Biogen (NSDQ:BIIB) seemed to be on the verge of becoming the first new Alzheimer’s drug to hit the market in almost two decades. Now, its potential fate is murkier given skepticisms voiced during an FDA advisory committee meeting today.
Eight of the experts in the committee disagreed that there was strong evidence in a Phase 3 to suggest that the drug was an effective Alzheimer’s treatment. One panel member voted for the drug while two were undecided when asked if the study 302 (also known as the Emerge trial) supported the effectiveness of the drug. For this question, panel members were asked to disregard results from a negative Phase 3 trial (study 301, also known as the Engage study).
Get the full story at our sister site, Drug Discovery and Development.