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Objective To evaluate the long-term safety and efficacy of nipocalimab, an FcRn blocker, in patients with generalized myasthenia gravis (gMG) from the Vivacity-MG3 ( NCT04951622) open-label extension (OLE) phase.Background There is a significant need for effective and safe treatments for gMG. In autoantibody-positive patients, nipocalimab showed marked improvement over baseline in the MG-ADL score compared to placebo in the phase 3 Vivacity-MG3 study.Methods In a 24-week double-blind study, autoantibody-positive (n=153) and triple-autoantibody-negative patients (n=43) with inadequately controlled gMG were randomized 1:1 to receive either nipocalimab+standard of care (SOC) or placebo+SOC. Those who completed the double-blind phase could enter the ongoing OLE. Safety was assessed for patients receiving at least one dose of study drug.Results Of 137 autoantibody-positive patients from the double-blind phase, 81 and 37 patients were assessed at OLE weeks 24 and 48, respectively. The mean change in MG-ADL was –5.73 and –5.97, respectively. Nipocalimab was well-tolerated with no new safety findings reported.Conclusion Nipocalimab maintained sustained disease control over 72 weeks, as measured by the MG-ADL scale, in autoantibody-positive gMG patients.GReynol1@ITS.JNJ.com