Minerva Neurosciences has received a refusal to file letter from the U.S. FDA regarding the company’s NDA for roluperidone for the treatment of negative symptoms in patients with schizophrenia.
Massachusetts-based Minerva had submitted its NDA back in August, after some initial struggles. The submission was supported by results from two late-stage, well-controlled studies in patients with moderate to severe negative symptoms and stable positive symptoms of schizophrenia (MIN-101C03 and MIN-101C07).
But the FDA had flagged some problems regarding the development of roluperidon back in Dec. 2020. The agency had cautioned that an NDA submission based on the then-current data from the phase 2b and phase 3 studies would be highly unlikely to be filed and that, at a minimum, there would be substantial review issues due to the lack of two adequate and well-controlled trials to support efficacy claims for this indication.
But given the unmet need, Minerva pushed forward. While positive symptoms of schizophrenia are generally well managed with antipsychotics, there are currently no approved therapies to treat negative symptoms of schizophrenia in the U.S. These negative symptoms can cause individuals with schizophrenia to withdraw from society, become disinterested or unable to complete tasks or feel pleasure
Now, the FDA has indicated that Minerva can request a Type A meeting to discuss the content of the refusal to file letter — and, according to Minerva's CEO Remy Luthringer, that's exactly what the company plans to do.
