FDA Rejects Minerva Neurosciences’ New Drug Application For Schizophrenia Medication

The U.S. Food and Drug Administration (FDA) rejected a New Drug Application (NDA) submitted by Minerva Neurosciences, Inc. for roluperidone as a treatment of negative symptoms in people with schizophrenia. The company is now reviewing the FDA’s Complete Response Letter to the NDA and intends to request a meeting to discuss the issues raised, and will attempt to address the feedback.

Remy Luthringer, Ph.D., executive chairman and chief executive officer of Minerva said “There is a critical need for a treatment for the negative symptoms of schizophrenia. We believe that roluperidone is a safe and effective therapy . . .