Minerva Neurosciences received a CRL from the FDA for roluperidone, citing insufficient data on effectiveness, antipsychotic co-administration, and long-term safety.
Minerva Neurosciences received a Complete Response Letter from the FDA regarding its drug roluperidone, intended for treating negative symptoms in schizophrenia patients. The FDA cited several deficiencies, including insufficient data on the drug's effectiveness, lack of data on concomitant antipsychotic administration, and inadequate long-term safety data. Minerva must now submit additional studies to address these concerns and provide more data on the drug's safety when co-administered with antipsychotic medications. The company's shares dropped in trading following the announcement.
February 27, 2024
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