NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) on Thursday announced that the U.S. Food and Drug Administration (FDA) has approved Caplyta as an add-on therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.
The approval was supported by two Phase 3 studies that met their primary endpoints, showing statistically significant and clinically meaningful improvements in depression symptoms compared with an oral antidepressant plus placebo.
Caplyta is already approved for bipolar I and II depression as well as for schizophrenia in adults.
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