August 4, 2022 is PDUFA date for resubmitted sNDA for Nuplazid for the treatment of Alzheimer’s disease psychosis.- Acadia Pharma
Acadia Pharmaceuticals Inc. has announced that it has received a target action date of August 4, 2022 from the FDA for its resubmitted supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
The FDA’s Division of Psychiatry has also advised the company that it is planning to hold an Advisory Committee meeting in connection with its review.
"We look forward to working with the Division during the course of their review and in preparation for the advisory committee meeting,” said Steve Davis, Chief Executive Officer. “With no FDA approved drug to treat Alzheimer’s disease psychosis, the hallucinations and delusions that Alzheimer’s patients endure represent a highly significant unmet need, dramatically altering the lives of both Alzheimer’s patients and their caregivers.
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