Acadia says FDA panel to meet next month to discuss Nuplazid label expansion
Grandbrothers/iStock Editorial via Getty Images


The commercial-stage biotech ACADIA Pharmaceuticals (NASDAQ:ACAD) announced on Monday that an expert panel of the FDA would meet next month to discuss the companyâs resubmitted marketing application for antipsychotic therapy pimavanserin targeted at patients with Alzheimerâs disease.

Pimavanserin is already indicated in the U.S. for the treatment of hallucinations and delusions associated with Parkinsonâs disease psychosis.
Last year, the FDA rejected the therapy for the same conditions in Dementia-related psychosis (DRP). In February, ACADIA (ACAD) resubmitted the supplemental New Drug Application ((sNDA)) targeting hallucinations and delusions associated with Alzheimerâs disease psychosis (ADP). The FDA assigned an action date for Aug. 04 to review it.

In connection with the review, the FDAâs Psychopharmacologic Drugs Advisory Committee is scheduled to meet on Jun. 17 to discuss the marketing approval for the new indication, the company said.
There are no FDA-approved therapies to treat hallucinations and delusions associated with ADP.