Johnson & Johnson Announces Submission Of A Supplemental New Drug Application To U.S. FDA Based Upon Long-term Data Evaluating The Safety And Efficacy Of Caplyta For The Prevention Of Relapse In Schizophrenia

Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA® is FDA approved to treat schizophrenia and is the first and only approved treatment for bipolar I and II depression as an adjunctive and monotherapy With the addition of CAPLYTA® to Johnson & Johnson's robust portfolio of therapies, the Company now offers the broadest range of treatment options for adults with schizophrenia 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, "For people living with schizophrenia, relapses can be devastating as they disrupt lives, undo hard-earned treatment progress toward patients' goals, and increase the risk of hospitalization with each episode," said Christoph U. Correll, M.D., Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, New York.a "CAPLYTA® substantially lowers the chance of relapse for patients compared to placebo, which is often a major source of anxiety and suffering for them and their families." The submission is supported by positive results from a Phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal trial, which on the primary endpoint found time to relapse during the 26-week double-blind treatment phase was significantly longer in patients receiving CAPLYTA® compared to those receiving placebo (p=0.0002). Treatment with CAPLYTA® was also associated with a 63 percent reduction in risk of relapse versus placebo (hazard ratio [95% CI] = 0.37, [0.22, 0.65]). The key secondary endpoint showed a significantly delayed time to all-cause discontinuation, including relapse, compared with placebo during the double-blind phase (p=0.0007). The safety profile of CAPLYTA® was consistent with the existing body of clinical data, and no new safety concerns were identified. The most commonly reported adverse event that was observed at a rate greater than or equal to 5% and twice the rate of placebo was headache.i which now offers the broadest range of oral and long-acting injectable treatment options to support each patient's individual treatment journey.