Acadia Pharmaceuticals Inc. (ACAD)

[IanFromSI]

What's your prediction for AdCom mtg?

Quality of life with Nuplazid was significantly improved for PDP pts.
i.e. T of Hallucinations, delusions and MDD in about a third of the pts suffering from MDD.

Surely ADP patients would benefit from an improved quality of life in their last years or months. ???


Acadia Pharmaceuticals Announces FDA Advisory Committee Meeting to Review Resubmission of Supplemental New Drug Application for NUPLAZID(R) (pimavanserin) for the Treatment of Alzheimer's Disease Psychosis Scheduled for June 17, 2022
2022-05-02 04:05:07 PM ET (BusinessWire)

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that a virtual meeting of the U.S. Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee to review the resubmitted supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis (ADP) has been scheduled for June 17, 2022. The target action date for the application is August 4, 2022.

"We appreciate our ongoing engagement with the FDA and look forward to a productive discussion on the clinical evidence supporting the positive benefit-risk profile for pimavanserin as a treatment for ADP at the upcoming Advisory Committee meeting," said Steve Davis, Chief Executive Officer. "The hallucinations and delusions that Alzheimer's patients endure represent one of the most significant burdens in this community, and one of the leading reasons for long-term care placement. There are no FDA-approved treatments for this critical public health need. Off-label use of multi-receptor acting antipsychotics with marginal efficacy and significant safety concerns can lead to poor patient outcomes, including worsening of cognition and motor function."