AGN - Receives Refusal to File Letter from FDA for Vraylar® (cariprazine) Supplemental New Drug Application (sNDA) for the Treatment of Negative Symptoms in Schizophrenia
- Announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for treatment of negative symptoms associated with schizophrenia in adult patients. VRAYLAR is an oral, once daily atypical antipsychotic approved in the United States for the treatment of schizophrenia and the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder.
- Upon its preliminary review, FDA determined that the sNDA for treatment of negative symptoms was not sufficiently complete to permit a substantive review.
- "We are disappointed with the FDA decision on our submission. We will request a meeting with FDA to discuss and determine our next steps. Vraylaris an important treatment option for patients suffering from bipolar I disorder and schizophrenia. We remain committed to our mental health program and to cariprazine and its potential as a treatment option for patients suffering from negative symptoms associated with schizophrenia," said David Nicholson Ph.D., Chief Research & Development Officer, Allergan. - Cariprazine is approved in Europe for the treatment of schizophrenia. The approval includes data from the 460-patient negative symptoms study which was conducted by Gedeon Richter and published in the Lancet on February 6, 2017.
- The Company will seek immediate guidance, and is in the process of planning a meeting with the FDA, to respond to the issues, and to seek clarification of what additional information will be required.