The FDA has rejected Minerva Neurosciences’ treatment for negative symptoms in schizophrenia, noting a lack of data and other factors that led to the Complete Response Letter.
Pictured: FDA sign at agency’s headquarters/iStock, JHVEPhoto
Minerva Neurosciences on Tuesday announced it has been issued a Complete Response Letter from the FDA for its anticipated schizophrenia treatment roluperidone.
The drug, listed as one of BioSpace’s FDA decisions to watch in the first quarter 2024, was rejected by the regulator due to several factors. Although one study did show statistical significance in the endpoint for roluperidone for the treatment of schizophrenia patients with negative symptoms, the FDA said it was “insufficient on its own” to establish “substantial evidence of effectiveness.”
The FDA also noted that the NDA submission lacked data on concomitant antipsychotic administration. In addition, the submission did not have the data to establish that the change in negative symptoms with the drug was clinically meaningful.
The regulator also cited the fact that the submitted safety database had an “inadequate number of subjects exposed to roluperidone” at the proposed dose of 64mg for at least 12 months. Minerva said in Tuesday’s announcement that the FDA also commented on clinical pharmacology, product quality, biopharmaceutics and other nonclinical issues.
The news sent Minerva’s stock price nosediving over 60% on Tuesday.
Minerva said that to address these issues the company must submit at least one positive, adequate, and well-controlled study to support the drug’s effectiveness. It must provide additional data to show the efficacy and safety of roluperidone co-administered with antipsychotic medicines to help an observed effect on negative symptoms.
“We are disappointed that the FDA has not approved roluperidone and will request a meeting to discuss the issues raised and attempt to address FDA’s feedback,” Minerva CEO Remy Luthringer said in a statement. “There is a critical need for a treatment for the negative symptoms of schizophrenia. We believe that roluperidone is a safe and effective therapy for negative symptoms of schizophrenia and we will review FDA’s feedback and consider our potential paths forward, including continuing to work closely with the FDA and providing any additional information as needed, to bring this much needed therapy to patients and physicians.”
The Massachusetts-based biotech has encountered roadblocks for its drug before. In 2022, the FDA issued a refusal to file notice to Minerva for unspecified reasons. However, at the time, the company said that research was showing that there was a more significant “subgroup of patients with schizophrenia who have moderate to severe primary negative symptoms and minimal positive symptoms.”
The FDA also required more data in four specific areas in March 2022.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
