Johnson & Johnson announces FDA approval of Caplyta

Johnson & Johnson announced that the U.S. FDA approved Caplyta as an adjunctive therapy with antidepressants for the treatment of major depressive disorder in adults. The approval, the first under J&J leadership following its acquisition of Intra-Cellular Therapies, provides patients with a safe and effective new treatment option that can enable a path to remission. Caplyta makes it easy to start and stay on treatment without the need for titration. Weight gain and other metabolic side effects that typically lead to discontinuation of care were similar to placebo. This approval marks the fourth indication for Caplyta, the first and only FDA-approved treatment for bipolar I and II depression in adults, as an adjunctive and monotherapy; also approved for the treatment of schizophrenia in adults.