The US Food and Drug Administration (FDA) has notified Gedeon Richter Plc and Allergan Plc that the FDA will require a three-month extension to complete its review of data supporting the resubmission of the companies’ new drug application (NDA) for cariprazine. Cariprazine is being reviewed for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. The FDA has determined that a recent response to an FDA question about the cariprazine NDA is a “major amendment,” requiring the three-month extension.

The NDA for cariprazine was submitted in late 2012. The agency issued a complete response letter in November 2013, and the companies resubmitted information in December 2014.

Cariprazine was discovered and co-developed by Gedeon Richter, a pharmaceutical company headquartered in Budapest, Hungary, and is licensed to Actavis, now Allergan, in the US and Canada. Cariprazine, an investigational drug is an atypical antipsychotic for the treatment of patients with schizophrenia and for patients with manic or mixed episodes associated with bipolar I disorder. The safety and efficacy of cariprazine was studied in a clinical trial program of more than 2700 patients. In addition, cariprazine is being investigated for the treatment of bipolar depression and adjunctive major depressive disorder.

Source: Allergan