The biopharma Minerva Neurosciences (Nasdaq:NERV) announced that it had received a refusal to file letter from the FDA for its New Drug Application (NDA) for roluperidone.
The NDA covered the use of the drug candidate as a treatment for the negative symptoms in schizophrenia patients. Negative schizophrenia symptoms can include social withdrawal, mood flatness and depression.
Drug candidates that get a refusal to file letter have slim chances of winning FDA approval.
Roluperidone is a 5-HT2A and sigma2 receptor antagonist.
FDA informed Burlington, Massachusetts–based Minerva Neurosciences that the company can ask for a Type A meeting to review the content of the refusal to file letter. Accordingly, the company plans to request such a meeting.
“We are disappointed that the FDA has not accepted our NDA for roluperidone,” said Remy Luthringer, CEO of Minerva Neurosciences. “Our goal remains to provide a new and much-needed therapeutic option to help patients and their families since there are currently no approved therapies to treat negative symptoms of schizophrenia in the United States.”
In its NDA, Minerva had included data from the Phase 3 MIN-101C03 and MIN-101C07 studies.
One obstacle is that roluperidone did not meet the primary efficacy endpoint in the U.S. MIN-101C07 study.
Minerva had planned on pursuing an indication of roluperidone as a monotherapy. However, the company has not yet investigated the use of the drug candidate in conjunction with an antipsychotic.
The company announced in August that it had filed an NDA with the FDA for roluperidone to treat negative symptoms of schizophrenia.
In an earlier meeting with FDA, officials from the agency had requested additional data on the potential impact of roluperidone when used with antipsychotics, the comparability of clinical data from schizophrenia patients inside and outside of the U.S. FDA also asked for additional evidence of the efficacy of roluperidone on negative symptoms and clarification of how clinicians could identify patients who could benefit from roluperidone.
According to a 2021 JAMA article, 84.5% of refusal to file letters cited scientific deficiencies as a problem with NDAs.
It is relatively rare for applicants to disclose the receipt of a refusal to file letter, which occurs in about 16% of cases.
Since its IPO in 2014, the company’s stock has lost approximately 93% of its value.
Filed Under: Neurological Disease
