Johnson & Johnson reports Phase 3 long-term data showing sustained efficacy and safety of nipocalimab (IMAAVY) in generalized myasthenia gravis patients over 120 weeks.
Written By: Mahathi Palivela, PharmD
Reviewed By: Pharmacally Editorial Team
Johnson & Johnson has presented new long-term data from its Phase 3 Vivacity-MG3 study (NCT04951622) and ongoing open-label extension (OLE), demonstrating sustained efficacy and safety of nipocalimab (IMAAVY®) in adults with Generalized Myasthenia Gravis.
The findings, shared at the American Academy of Neurology Annual Meeting 2026, include up to 120 weeks of follow-up, among the longest reported for a FcRn blocker in this indication.
Patients treated with IMAAVY showed sustained improvements in disease severity, with mean reductions of 6.47 points in MG-ADL and 5.97 points in QMG scores, reflecting improved daily function and muscle strength. Half of the patients achieved minimal symptom expression (MSE), and 32% maintained this state for at least eight weeks.
Treatment was also associated with a reduction in corticosteroid use, with 57% of patients reaching low-dose levels, alongside a greater than 64% reduction in total immunoglobulin G (IgG), including pathogenic autoantibodies.
A post-hoc analysis from the 24-week double-blind phase showed that patients receiving nipocalimab plus standard of care were four times more likely to achieve sustained MSE compared with placebo.
Patients who maintained minimal symptoms experienced the greatest improvements in quality of life, as measured by the MG-QoL-15r scale.
Commenting on the findings, Constantine Farmakidis, MD, noted that the data extending beyond two years support the durability of disease control observed in earlier phases and may help inform clinical decision-making.
Chris Gasink, MD, Vice President of Medical Affairs at Johnson & Johnson, stated that the results reinforce confidence in nipocalimab’s ability to provide sustained disease control across a broad patient population and address unmet needs in gMG.
The Vivacity-MG3 study enrolled 199 adults with gMG who had an insufficient response to standard therapies, with participants randomized to receive nipocalimab plus standard of care or placebo during a 24-week double-blind phase, followed by an ongoing extension assessing long-term outcomes.
Johnson & Johnson also reported that the EPIC study, a head-to-head trial comparing nipocalimab with efgartigimod in FcRn inhibitor–naïve patients, is currently enrolling.
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About the Writer
Mahathi Palivela is pursuing PharmD and has a strong interest in Clinical Pharmacy and Patient safety. She is passionate about handling and analyzing patient data, and translating clinical insights into clear, meaningful summaries. She aims to apply this interest in Medical Writing and Pharmacovigilance, focusing on improving patient outcomes through careful data interpretation and communication .