On 16 February, Acadia Pharmaceuticals Inc, announced that the company has resubmitted its supplemental New Drug Application for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease (AD) psychosis to the US Food and Drug Administration (FDA). The resubmission came after a letter received in April 2021 from the FDA, stating that the application of pimavanserin for the treatment of dementia-related psychosis cannot be approved. This application was supported by findings from the HARMONY Phase III trial, which evaluated the safety and efficacy of pimavasenrin for the treatment of hallucinations and delusions associated with Lewy Bodies, vascular dementia and frontotemporal dementia.
The FDA did not mention any safety issues, it raised concerns regarding statistically significant data in some of the subgroups of dementia and insufficient numbers of participants with certain less common dementia subtypes. Instead of a broad indication for dementia-related psychosis, Acadia has submitted a New Drug Application for pimavanserin specifically for hallucinations and delusions associated with AD psychosis. The resubmission provides additional analyses from two clinical studies, the Phase III HARMONY and the Phase II study-019 specifically done in people with AD psychosis. These additional analyses are intended to address the concerns raised by the FDA.
