Overview
- The decision adds a new indication to a label that already includes schizophrenia and bipolar I and II depression.
- In two pivotal add‑on studies, Caplyta reduced depressive symptoms by 4.9 and 4.5 points versus placebo over six weeks, outperforming improvements reported for other antipsychotics approved for depression.
- J&J cites an open‑label study showing 80% response and 65% remission and reports fewer issues such as sexual dysfunction or weight gain than are common with some antidepressants.
- The company views the expanded use as a key step toward a roughly $5 billion annual sales target in a U.S. market with about 22 million people affected by major depressive disorder.
- The approval reinforces J&J’s psychiatric portfolio that includes Spravato and helps counterbalance the earlier shutdown of its aticaprant program.