FDA to Consider Nuplazid to Treat Dementia-related Psychosis

FDA to Consider Nuplazid to Treat Dementia-related Psychosis
The U.S. Food and Drug Administration (FDA) has accepted a request by Acadia Pharmaceuticals' that  Nuplazid (pimavanserin) be approved for a new indication: the treatment of delusions and hallucinations associated with dementia-related psychosis. The company's supplemental new drug application, which was submitted in June, was granted standard review status. The FDA’s decision is expected by April 3, 2021. No issues were found with the application, and the agency is not planning to request an advisory committee meeting — a process used to solicit scientific advice from independent evaluators. “We are pleased that the FDA has accepted our sNDA for filing and we will be working closely with the FDA to facilitate completion of the review in a timely manner,” Steve Davis, CEO of Acadia, said in a press release. An estimated 8 million people in the U.S. have dementia, and about 30%  — 2.4 million people — experience dementia-related psychosis. While half of these patients will be treated for psychosis, no medication is specifically indicated as a treatment for its related hallucinations and delusions. “If approved, Nuplazid would be the first therapy indic
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