Many of us listened intently today as the US Food and Drug Administration convened a panel of expert members of an advisory committee to review the submitted materials for potential approval of Biogen’s candidate treatment for early Alzheimer’s disease, aducanumab.
The meeting was notable on many levels. Advocates made clear and compelling demonstrations of why new therapies are so desperately needed for this disease. The experts, however, were equally clear that the available data from a still limited number of studies, only one of which was actually positive, do not meet the current standards for drug approval in the United States.
We will now eagerly await a decision from the FDA. The implications are great, for patients and caregivers, as well as researchers. In any case, however, the need for new discoveries, a national portfolio of clinical trials, and further improved therapies will remain great.