Minerva’s Roluperidone for Schizophrenia Symptoms Denied Approval by FDA

- Minerva Neurosciences' shares plummeted on news that the U.S. Food and Drug Administration (FDA) rejected their marketing application for roluperidone, intended to treat negative symptoms of schizophrenia.
- The FDA cited multiple clinical deficiencies in Minerva's New Drug Application (NDA), including insufficiency of data to support the drug's effectiveness, lack of evidence demonstrating clinical meaningfulness of improvements, absence of data on concomitant antipsychotic administration, and inadequate exposure duration for a significant number of patients.
- Despite the setback, Minerva's CEO, Remy Luthringer, expressed intent to meet with the FDA to explore potential paths forward, including providing additional information as needed.
- The FDA suggested that Minerva should conduct another "well-controlled" clinical trial to address the deficiencies identified in the NDA.
- Previously, Minerva experienced a similar setback when the FDA initially refused to accept the NDA for roluperidone, but Minerva eventually succeeded in appealing the decision in 2023.
- Other companies, such as Karuna Therapeutics, continue to pursue treatments for schizophrenia, with their drug KarXT (xanomeline-trospium) potentially reducing both positive and negative symptoms of the neurological disorder.

Date Published: The search results indicate the latest coverage of this event occurred within the past few days, with dates ranging from October 1, 2022, to March 4, 2024.