FDA committee: Evidence does not support pimavanserin for Alzheimer’s disease psychosis

Acadia Pharmaceuticals Inc. announced the outcome of the FDA advisory committee meeting on the use of pimavanserin for treating hallucinations and delusions associated with Alzheimer’s disease psychosis.

The Psychopharmacologic Drugs Advisory Committee (PDAC) voted nine to three that evidence presented did not support a conclusion that Nuplazid (pimavanserin, Acadia) is effective for the treatment of hallucinations and delusions in those with Alzheimer’s.

“We are disappointed with the outcome of today’s vote,” Acadia CEO Steve Davis said in the release. “We continue to believe there is substantial evidence across multiple independent clinical studies and endpoints that support the efficacy of pimavanserin in [Alzheimer’s disease psychosis].”

Nuplazid was approved in the United States in 2016 as the first and only treatment for hallucinations and delusions associated with Parkinson’s disease psychosis. In May, the FDA announced it would review a resubmitted supplemental drug application for the oral therapeutic, a selective serotonin inverse agonist and antagonist that targets 5-HT2A receptors, which are thought to play an important role in neuropsychiatric disorders.

According to the release, 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 Aug. 4.

Editor’s note: This article was revised June 21, 2022, to more accurately reflect the outcome of the committee meeting. Healio regrets the error.