FDA Approves Caplyta For Major Depressive Disorder In Adults

Johnson & Johnson (J&J) announced approval from the Food and Drug Administration (FDA) for Caplyta (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. The approval provides a safe and effective new treatment option that can enable a path to remission. 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. It is also approved for the treatment of schizophrenia in adults.

The FDA approval was based on positive results from two . . .