SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) has unveiled new data demonstrating the efficacy of IMAAVY™ (nipocalimab-aahu) for the treatment of generalized myasthenia gravis (gMG). Presented at the European Academy of Neurology (EAN) 2025 Congress in Helsinki, Finland, the findings revealed consistent and sustained disease control with IMAAVY compared to other approved FcRn blockers.
The data, drawn from an indirect treatment comparison (ITC) that integrated results from the pivotal Phase 3 Vivacity-MG study, showed that IMAAVY offered comparable onset of symptom relief by Week 1 and sustained improvements in MG-ADL scores at various time points, up to 24 weeks. These findings were validated using multiple ITC methods.
Population-adjusted ITCs found significantly greater mean improvements in MG-ADL scores with IMAAVY from Weeks 8 to 24 versus one comparator and from Weeks 10 to 14 versus another. Placebo-adjusted ITCs similarly highlighted statistically significant efficacy of IMAAVY at Weeks 10 and 12 compared to alternative treatments.
“These analyses provide useful population-adjusted comparative data and add to the body of evidence supporting the use of IMAAVY for the treatment of gMG for certain patients,” said Dr. Saiju Jacob, Professor of Immunology and Immunotherapy at the University of Birmingham, UK. “The significantly greater mean improvements on MG-ADL scores with IMAAVY reflect important new evidence of the ongoing need for sustained disease control in a chronic condition like gMG.”
A key differentiator for IMAAVY is its biweekly dosing regimen, which offers a predictable treatment schedule, eliminating the need for symptom relapse prior to reinitiating therapy. This predictability could aid patients and healthcare providers in making more informed decisions about long-term disease management.
“At Johnson & Johnson, we recognize that for people living with gMG, the goal isn’t just temporary relief, but rather sustained disease control,” said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Immunology Disease Area Leader at Johnson & Johnson Innovative Medicine. “This analysis provides additional insights into the profile of IMAAVY and highlights its potential as a reliable treatment option for appropriate patients aged 12 and older living with gMG.”
Currently approved in the U.S. for patients with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody-positive gMG, Johnson & Johnson has also submitted a Marketing Authorisation Application to the European Medicines Agency for nipocalimab in gMG.
These findings further establish IMAAVY as a critical advancement in the treatment landscape for gMG, offering hope for sustained disease management in a condition requiring ongoing, reliable care.
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