FDA Approves J&J’s Caplyta To Prevent Schizophrenia Relapse

The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Caplyta (lumateperone) 42 mg, expanding its label to include relapse prevention in adults with schizophrenia. Johnson & Johnson announced the approval, which is based on long-term safety and efficacy data from a Phase 3 clinical trial.

Schizophrenia is a chronic brain disorder affecting cognition, emotion, speech, and behavior.

Caplyta is an oral, once-daily atypical antipsychotic. It was previously approved for schizophrenia, major depressive disorder (MDD) as an adjunctive therapy with antidepressants, and depressive episodes associated with bipolar I or II disorder . . .