Posted by Michael Wonder on 09 Jul 2025
Supplemental new drug application submitted to US FDA for Caplyta (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo
8 July 2025 - Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo.
Johnson & Johnson announced today the submission of a supplemental new drug application to the US FDA based upon long-term data evaluating the safety and efficacy of Caplyta (lumateperone) for the prevention of relapse in schizophrenia.
