FDA Advisory Committee does not support pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis.- Acadia Pharma.
Acadia Pharmaceuticals Inc. announced the outcome of the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) meeting for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
The PDAC voted 9 to 3 that the evidence presented does not support a conclusion that pimavanserin is effective for the treatment of hallucinations and delusions in the ADP population.
The FDA asked the PDAC for advice and recommendations regarding the evidence that pimavanserin is effective for the treatment of hallucinations and delusions associated with ADP. The FDA is not bound by the PDAC’s recommendations, but takes its advice into consideration when making decisions on drug applications. The FDA’s target action date is August 4, 2022.