Minerva Neurosciences Files NDA for Schizophrenia Treatment
Minerva Neurosciences (Nasdaq: NERV) has filed a New Drug Application (NDA) with the FDA for roluperidone for the treatment of negative symptoms in patients with schizophrenia.
The decision to file the NDA follows Minerva’s request for formal dispute resolution and appeal of FDA’s October 2022 refuse to file letter. In granting the appeal, the FDA deciding official agreed with the Company that the issues cited in the refuse-to-file decision should be considered during FDA’s review of the NDA.
The company’s share price rose more than 70% following the news.
Highlights
Schizophrenia affects 20 million people worldwide and negative symptoms can cause individuals to withdraw from society, become disinterested or unable to complete tasks or feel pleasure.
Negative symptoms are believed to be one of the main risk factors leading to ultra-high risk adolescents developing full blown schizophrenia.
Negative symptoms are a major source of disability in people with schizophrenia and there have been no approved treatments to date.
The company said it “looks forward to continuing to work with the FDA with the ultimate goal of obtaining approval of roluperidone as the first approved treatment for negative symptoms of schizophrenia for the benefit of patients, their families, caregivers, and physicians.”
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat central nervous system (CNS) diseases. The company’s goal is to transform the lives of patients with improved therapeutic options. Minerva’s portfolio of compounds includes roluperidone (MIN-101), in clinical development for negative symptoms of schizophrenia, and MIN-301 for Parkinson’s disease.
