FDA approves CAPLYTA for relapse prevention in schizophrenia, with 63% lower relapse risk versus placebo

The FDA approved an expanded use of CAPLYTA (lumateperone) for the prevention of relapse in schizophrenia. In a randomized withdrawal study, patients on CAPLYTA had a 63% lower risk of relapse than those on placebo, and 84% stayed relapse-free over six months. The label update strengthens the neuroscience growth case that J&J built with the Intra-Cellular Therapies acquisition.

• Relapse risk 63% lower than placebo (hazard ratio 0.37)
• 84% of patients were relapse-free over six months
• Based on the randomized withdrawal Phase 3 Study 304
• CAPLYTA came to J&J with the Intra-Cellular Therapies acquisition