Posted by Michael Wonder on 28 Apr 2026
FDA approves Caplyta (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia
27 April 2026 - Johnson & Johnson announced today that the US FDA has approved a supplemental new ddrug application based on long-term data evaluating the safety and efficacy of Caplyta (lumateperone) for the prevention of relapse in schizophrenia.
In the Phase 3, double-blind, randomised withdrawal trial supporting this update, Caplyta significantly extended time to relapse versus placebo during the 26 week double-blind treatment period (p=0.0002), helping support long-term stability for adults living with schizophrenia.
