Posted by Michael Wonder on 27 Sep 2018
Allergan announces FDA acceptance of supplemental new drug application for Vraylar (cariprazine)
26 September 2018 - Application seeks to expand Vraylar indication to include the treatment of bipolar depression.
Allergan today announced that the U.S. FDA has accepted for review the company's supplemental new drug application for Vraylar (cariprazine), seeking to expand the indication to include the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults in the current product label.
The application is supported by data from three pivotal trials, including RGH-MD-53, RGH-MD-54 and RGH-MD-56. In all three pivotal studies, cariprazine demonstrated greater improvement than placebo for the change from baseline to week 6 on the Montgomery Asberg Depression Rating scale total score. Both cariprazine 1.5 mg and 3 mg demonstrated superiority to placebo in reducing depressive symptoms associated with bipolar I depression.
