FDA Rejects Minerva's Schizophrenia Drug in CRL

Minerva Neurosciences recently received a Complete Response Letter from the FDA regarding its drug roluperidone, intended for the treatment of schizophrenia. The FDA's decision was based on a number of considerations, including the insufficiency of one study to prove substantial effectiveness of roluperidone for negative symptoms in schizophrenia patients. The FDA also pointed out the absence of data on the concurrent use of antipsychotic medications and the lack of evidence to show that the drug's impact on negative symptoms was clinically significant.

Furthermore, the FDA highlighted that the safety database provided was inadequate, with too few subjects exposed to the recommended 64mg dose of roluperidone for a minimum of 12 months. Other issues raised by the FDA included concerns about clinical pharmacology, product quality, and biopharmaceutics.

Following the announcement, Minerva's stock price plummeted by over 60%. To address the FDA's concerns, Minerva must submit a well-controlled study that demonstrates the drug's effectiveness and provide additional data to prove the efficacy and safety of roluperidone when used alongside antipsychotic medications.

Minerva's CEO, Remy Luthringer, expressed disappointment and stated that the company will seek a meeting with the FDA to discuss the issues and work towards a resolution. He emphasized the importance of roluperidone as a potential treatment for the negative symptoms of schizophrenia and pledged to review the FDA's feedback and consider all possible paths forward, including close collaboration with the FDA and providing any necessary additional information.

This is not the first time Minerva has faced challenges with its drug. In 2022, the FDA issued a refusal to file notice for unspecified reasons. However, Minerva maintained that its research indicated a significant subgroup of schizophrenia patients with moderate to severe primary negative symptoms and minimal positive symptoms. The FDA also requested more data in four specific areas in March 2022.

The company is now tasked with addressing these concerns to bring its much-needed therapy to patients and healthcare professionals. Despite the setback, Minerva remains committed to advancing its research and development efforts to meet the critical needs of the schizophrenia patient community.