Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo

Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia. CAPLYTA® is the newest addition to Johnson & Johnson's portfolio of schizophrenia therapies, which now offers the broadest range of oral and long-acting injectable treatment options to support each patient's ind