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Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
FDA confirms acceptance of the filing of the NDA for roluperidone Application has been granted a standard review FDA has assigned a Prescription Drug User Fee
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"FDA confirms acceptance of the filing of the NDA for roluperidone Application has been granted a standard review FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024 BURLINGTON, Mass., May 10, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that on May 8, 2023, it received confirmation from the U.S. Food and Drug Administration (FDA) that the Company’s New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia has been filed in accordance with the recent Appeal Granted letter dated April 27, 2023 and assigned a standard review classification. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024. The FDA advised that it identified potential review issues that had been previously cited in the refuse-to-file decision letter, which included those discussed at the Type C meeting in March 2022. “The filing of the NDA is an important event for Minerva and a step forward to our goal to treat those patients suffering negative symptoms of schizophrenia. If approved, we believe roluperidone could be an important new option to address the serious unmet need faced by that group of patients with schizophrenia whose negative symptoms are a major source of disability and adversely impact their daily quality of life,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. About RoluperidoneRoluperidone is an investigational drug that has been shown to block serotonin, sigma and α-adrenergic receptors that are all involved in the regulation of important brain functions, including mood, cognition, sleep, and anxiety. Roluperidone was designed to avoid a direct blockade of dopaminergic receptors (the key pharmacological target for first- and second-generation antipsychotics), while maintaining blockade of a specific subtype of serotonin receptor called 5-HT2A (an additional key target of second-generation antipsychotics) as well as additional pharmacological targets (sigma2 and adrenergic-α1A). About Schizophrenia and Negative SymptomsSchizophrenia is a chronic, severe, and debilitating type of mental illness characterized b...