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

      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 receives FDA approval for IMAAVY™ (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG)

      First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older IMAAVY delivered rapid and substantial reduction in immunoglobulin G (IgG) levels, one of the root causes of gMG, in both the adult and pediatric pivotal studies gMG patients taking IMAAVY demonstrated 20 months of lasting disease control and symptom relief in the pivotal Vivacity-MG3 study and ongoing open-label extension (OLE)

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      Our transformational medicines are developed with rigorous science and unwavering compassion to provide the greatest impact for patients. We create new and groundbreaking medicines to change the future of health. Our scientists and researchers are pioneering the path from lab to life and championing patients each step of the way.
      At Johnson & Johnson, we are leading where medicine is going, with a relentless focus on bringing transformational medical innovation to patients who are waiting. Our team’s deep expertise and global reach are helping us reimagine how devastating diseases are treated and cured, delivering hope and better care for millions of patients and their families around the world.
      Jennifer L. Taubert
      Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson

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