The U.S. Food and Drug Administration advisory panel voted against the approval of Acadia Pharmaceutical’s drug for hallucinations and delusions associated with Alzheimer’s disease psychosis on Friday.
The advisory voted 3 to 9 with no abstention after eight hours of discussion. The panel concluded that the studies were not enough to support the efficacy of Acadia Pharmaceutical’s pimavanserin (trading as Nuplazid), against Alzheimer’s disease psychosis (ADP).
The FDA is not bound by its advisory committee’s recommendations, though it often follows the panel’s advice in decisions for drug applications.
Among the experts that voted “yes,” the general rationale revolved around the drug already being seen as effective and safe in the Parkinson’s psychosis population and the unmet need for the drug for patients affected by psychosis from Alzheimer’s disease….