Acadia Pharmaceuticals Inc.announced that the FDA has accepted for filing its supplemental New Drug Application (sNDA) for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA has assigned a standard review with a PDUFA (Prescription Drug User Fee Act) action date of April 3, 2021.
The FDA has also informed the company that it has not identified any potential review issues at this point in their evaluation and at this time they are not planning to hold an Advisory Committee meeting.Dementia is highly prevalent, affecting approximately 8 million people in the U.S., and is expected to grow as the population ages. Approximately 30 percent, or 2.4 million people, experience dementia-related psychosis and only half of them, or 1.2 million, are diagnosed and treated. <
The sNDA is supported by results from the pivotal Phase III HARMONY study, which met its primary endpoint, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo (hazard ratio = 0.353; one-sided p=0.0023).