Johnson & Johnson submits sNDA to U.S FDA for CAPLYTA

Johnson & Johnson announced 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 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 individual treatment journey. “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 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.”