FDA approved supplemental NDA expanding Caplyta label to prevent relapse in schizophrenia, based on long‑term data.
Phase 3 trial showed 63% lower relapse risk versus placebo, with 84% of patients relapse‑free over six months.
Safety remained consistent; headache occurred in ≥5% patients, about twice the placebo rate, with no new safety concerns.
Schizophrenia impacts ~2.8 million US adults, costing $366.8 billion in 2024, highlighting market relevance of the approval.