Acadia resubmits sNDA for pimavanserin for Alzheimer’s disease psychosis

Acadia Pharmaceuticals Inc. has resubmitted its supplemental new drug application to the FDA for pimavanserin for treating hallucinations and delusions linked to Alzheimer’s disease psychosis.

The resubmission came as a response to the FDA’s complete response letter in April 2021 to the initial sNDA for a proposed indication for pimavanserin for treating dementia-related psychosis. With the resubmission, Acadia has included additional data from two prior clinical studies, HARMONY1 and Study-0192, to support the proposed indication for treating Alzheimer’s disease psychosis, with the intention of addressing the issues the FDA raised in its letter.