FDA declines the approval of Acadia’s antipsychotic drug pimavanserin because of its ineffectiveness to treat hallucinations and delusions.
The United States Drug and Food Administration did not approve the expanded usage of Acadia Pharmaceuticals Inc’s antipsychotic drug. The drug is used for treating psychosis, which is linked with Alzheimer’s disease.
A conclusion was given by the health regulator that there are limitations in the interpretability of the antipsychotic drug‘s study. Moreover, they said that there is an extra study required based on what the company claimed.
The decision by the US regulators is given approximately a month after the panel votes of outside advisors. Furthermore, the votes were 9 and 3. It did not support the data conclusion of the drug, which is, pimavanserin is effective to treat hallucinations and delusions linked with Alzheimer’s disease.
The chief of Acadia Executive Officer, Steve Davis said that they were disappointed with what the outcome was. He said,
“We are disappointed with this outcome. The treatment of Alzheimer’s disease psychosis continues to be an area of high unmet need, for which there is no approved therapy.”
Second Approval of Pimavanserin
Acadia tried again for the second time to secure approval for the drug’s expanded use in April 2021. However, FDA told Acadia that the clinical trial is insufficient and does not support the approval of pimavanserin in patients suffering from psychosis in association with dementia.
Moreover, the company also resubmitted their application focusing on just Alzheimer’s patients. Moreover, the drug that is sold under the name of Nuplazid has been approved for patients with Parkinson’s disease as a similar indication.
