Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class for broadest population of myasthenia gravis patients
First-and-only FcRn blocker to demonstrate superiority in activities of daily living (MG-ADLa) over placebo when added to standard of care over 24 weeks in antibody positive patients: anti-AChR+, anti-MuSK+, anti-LRP4+
HELSINKI, June 28, 2024 /PRNewswire/ --Â Johnson & Johnson (NYSE: JNJ) today announced positive results from the nipocalimab Phase 3 Vivacity-MG3 study in patients with generalized myasthenia gravis (gMG). Patients treated with nipocalimab plus standard of care (SOC) achieved superiority over placebo plus SOC as measured by the primary endpoint of improvement in the MG-ADL score from baseline over 24 weeks. These data are included in a presentation and are among eight abstracts that Johnson & Johnson will present at the European Academy of Neurology (EAN) 2024 Congress1Â and will be included in submissions to regulatory authorities later this year.
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"The sustained response of nipocalimab over six months among this broad myasthenia gravis population is an important finding given the chronic, unpredictable exacerbations typically seen with myasthenia gravis," said Carlo Antozzi, M.D., Neuroimmunology and Muscle Pathology Unit of the Neurological Institute Foundation C. Besta of Milan, Italyb. "We are encouraged by the potential of nipocalimab to uniquely help address this gap for people living with myasthenia gravis."
The double-blind placebo-controlled study enrolled a broad population of anti-AChR+, anti-MuSK+ and/or anti-LRP4+ patients, which account for approximately 95 percent of the gMG patient population.2Â Patients receiving nipocalimab plus SOC improved by 4.70 points on the MG-ADL, significantly more than the 3.25 point improvement from baseline observed with placebo plus SOC from baseline over Weeks 22, 23 and 24 (P=0.002)c. For someone living with gMG, a 1- to 2-point change on MG-ADL may be the difference between normal eating and frequent choking on food, or shortness of breath at rest and being on a ventilator.3Â In addition to achieving this primary endpoint, critical secondary endpoints were also met:
- Improvement in strength and function of different muscle groups, as measured by QMGd, was significantly greater with nipocalimab plus SOC compared with placebo plus SOC over Weeks 22 and 24 (P
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