Posted by Michael Wonder on 28 May 2019
Allergan and Gedeon Richter receive U.S. FDA approval for expanded use of Vraylar (cariprazine) in the treatment of bipolar depression
28 May 2019 - New indication makes Vraylar first and only dopamine and serotonin partial agonist to treat the full spectrum of bipolar I symptoms in manic, mixed, and depressive episodes.
Allergan and Gedeon Richter today announced that the U.S. FDA has approved a supplemental new drug application for Vraylar (cariprazine) for expanded use to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults. Vraylar is also approved in the U.S. to treat manic or mixed episodes associated with bipolar I disorder in adults.
The FDA approval for the expanded indication of Vraylar is based on three pivotal trials, including RGH-MD-53, RGH-MD-54 and RGH-MD-56, in which cariprazine demonstrated greater improvement than placebo for the change from baseline to week six on the Montgomery Asberg Depression Rating scale total score.
