The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 12 to 2 that the benefits outweigh the risks of Acadia’s (ACAD) drug Nuplazid™ (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease.
The Prescription Drug User Fee Act (PDUFA) action date for the FDA decision is May 1, 2016.
Nuplazid’s NDA was granted a breakthrough designation and Priority Review status for the treatment of psychosis associated with Parkinson’s disease and a Breakthrough Therapy.
The Advisory Committee provides the FDA with independent expert advice and . . .