BRIEF—AbbVie submits Vraylar sNDA for adjunctive treatment of MDD

US drugmaker AbbVie has submitted a supplemental New Drug Application (sNDA) for Vraylar (cariprazine) to the US Food and Drug Administration (FDA) for the adjunctive treatment of major depressive disorder (MDD) in patients who are receiving ongoing antidepressant therapy.

The submission is supported by Phase III trial data.

Michael Severino, vice chairman and president, AbbVie, said: “Many people living with MDD struggle to find a treatment that reduces their depressive symptoms, with many taking years to find the right treatment. Cariprazine, when added to ongoing antidepressant treatment in patients with MDD, demonstrated that it can reduce depressive symptoms.”

Vraylar is already an FDA-approved product to treat adults with depressive, acute manic and mixed episodes associated with bipolar I disorder, as well as schizophrenia. It is being co-developed by AbbVie and Gedeon Richter.