US FDA extends review period for bipolar drug cariprazine to September

The US Food and Drug Administration has told Hungary’s largest drugmaker Gedeon Richter (RICHT: HB) and Allergan (NYSE: AGN) that it will require a three-month extension to complete its review of data supporting the resubmission of the New Drug Application for cariprazine.

The drug 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 NDA for cariprazine was submitted in late 2012. The FDA issued a complete response letter (CRL) in November 2013, and the companies resubmitted information in December 2014. The FDA has determined that a recent response to an FDA question about the cariprazine NDA is a ‘major amendment’ which requires the three-month extension.

David Nicholson, executive vice president, global R&D of Allergan, said: “We continue to work with the FDA during their review of the cariprazine NDA. The unmet need of patients suffering with bipolar I disorder and schizophrenia continue to be of paramount importance to Allergan and Richter. We remain committed to pursuing this important treatment option for patients and physicians.”