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Minerva Neurosciences Provides Update from Type C Meeting with FDA and Next Steps in Preparation for Submission of a New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
Company to Host Webcast Wednesday, April 13, 2022 at 11am ETWALTHAM, Mass., April 07, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"Company to Host Webcast Wednesday, April 13, 2022 at 11am ETWALTHAM, Mass., April 07, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company developing therapies to treat central nervous system (CNS) disorders, announced today that it has received the official meeting minutes from the Type C meeting with the U.S. Food and Drug Administration (FDA) held on March 2, 2022, regarding development of roluperidone for the treatment of negative symptoms in schizophrenia. The primary purpose of the meeting was for Minerva to seek the FDA’s agreement on the use of roluperidone as monotherapy for the treatment of negative symptoms of schizophrenia in the subgroup of patients with moderate to severe negative symptoms and stable positive symptoms. Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva Neurosciences said, “Both the patient and medical communities recognize the need for a radical new treatment to address the negative symptoms of schizophrenia. Presently, there is no approved treatment for negative symptoms in the United States. I believe roluperidone has the potential to transform the lives of people who are unable to participate in and enjoy everyday activities due to their negative symptoms. We are mindful of our responsibility to patients and would particularly like to thank Dr. Tiffany Farchione, Director, Division of Psychiatry and Dr. Billy Dunn, Director, Office of Neuroscience, and their colleagues for their support at the Type C meeting. We are committed to working with the Division and continuing an open dialogue in preparation for a potential NDA submission for roluperidone in the summer, subject to guidance from the Division.” The Division agreed that there is an unmet need for negative symptom treatments and restated its position following the November 2020 Type C meeting in which they indicated a marketing application was highly unlikely to be filed. The Division also stated at the November 2020 meeting 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 novel indication. The Division acknowledged at the time that the studies appear to show promising signals and encouraged Minerva to continue the drug development program for this i...