Johnson & Johnson Highlights New Two-Year Data and Real-World Insights for IMAAVY®
Johnson & Johnson (JNJ) announced new findings on IMAAVY® (nipocalimab-aahu) for the treatment of generalized myasthenia gravis (gMG) across 15 novel abstracts to be presented at the 2026 Myasthenia Gravis Foundation of America (MGFA) Scientific Session and American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. These data include two-year results from the Phase 2/3 study in adolescents which demonstrated sustained disease control while on IMAAVY, with patients maintaining improvements in daily function and muscle strength alongside reductions in corticosteroid use. In addition, a retrospective survey of healthcare professionals (HCPs) treating adults with anti-AChRa or anti-MuSKb antibody-positive gMG provides insight into how fluctuating symptoms and the resulting unmet need for more sustained disease control can drive transitions from one advanced therapy to another.
Two-year findings from the Vibrance-MG Phase 2/3 long-term extension study showed sustained disease control in adolescents living with anti-AChR+ gMG alongside continued reductions in corticosteroid use. These findings are consistent with improvements observed in adults in the open-label extension of the Phase 3 Vivacity-MG3 study:
- Daily function and muscle strength improvements were sustained through Week 108: Among participants with available data, mean changes from baseline were −2.88 points in MG-ADL and −8.25 points in QMG at Week 108 consistent with findings at Week 4, 24 and at all intervening time points through two years.
- Corticosteroid reductions were observed: Of the six adolescent patients taking corticosteroids at study entry, three reduced their dose while one discontinued after two years on IMAAVY.
- No new safety signals were identified through up to two years of treatment: The safety profile of IMAAVY in adolescents was similar to that reported in adults.
“For adolescents living with generalized myasthenia gravis, unpredictable muscle weakness and symptoms such as eyelid droop and double vision can affect more than physical health; they can disrupt school, friendships and their growing independence,” says Jonathan Strober, MD, Director, Pediatric Neuromuscular Program. “The two-year Vibrance-MG results are encouraging and add to our growing body of evidence of IMAAVY in adolescents with continued improvements in daily function, muscle strength and reductions in corticosteroid use observed over time.”
Findings from a retrospective survey of HCPs treating adults with anti-AChR+ or anti-MuSK+ gMG highlight how the need for more sustained disease control can shape treatment decisions—from dissatisfaction with fluctuating symptoms on a prior advanced therapy, to seeking improved efficacy and a consistent treatment schedule when initiating IMAAVY:
- Fluctuating symptom control was the most common driver for discontinuing prior therapy: HCPs cited fluctuating symptom control (54.6%) suggesting that a lack of sustained disease control remains an important unmet need shaping treatment decisions.
- Consistent treatment schedule and hope for improved efficacy were the top drivers for initiating IMAAVY: Among 97 patients who transitioned from prior advanced therapies to IMAAVY, HCPs most frequently cited preference for a consistent treatment schedule (62.9%) and hope for improved efficacy (56.7%) as reasons for initiating IMAAVY.
- Positive outcomes reported following transition to IMAAVY: HCPs reported that 73.2% of patients were “much improved” or “very much improved,” while 76.4% of patients receiving prednisone reduced their dose and 5.5% discontinued use—an important treatment objective for people living with gMG.
“People living with generalized myasthenia gravis can experience fluctuating symptoms that make sustained disease control an important treatment goal. The HCP survey findings provide important insight into the factors shaping treatment decisions, with fluctuating symptom control emerging as the leading reason healthcare professionals reported for discontinuing prior therapy,” says David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. “The broader clinical evidence for IMAAVY across adolescents and adults, including reductions in corticosteroid use, further informs our understanding of the potential for IMAAVY to deliver sustained disease control across a broad population of people living with gMG.”
IMAAVY is an immunoselective treatment designed to substantially reduce pathogenic immunoglobulin G (IgG), a root cause of gMG, while preserving B-cell function. It is currently the only FcRn blocker approved for pediatric patients (12 years of age and older) with anti-AChR or anti-MuSK antibody-positive gMG by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
For more information, visit www.jnj.com.
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