Johnson & Johnson (NYSE: JNJ) announced on Monday that its FcRn blocker IMAAVY (nipocalimab-aahu) demonstrated consistent and sustained disease control compared to other approved FcRn blockers in adults with generalized myasthenia gravis (gMG), according to new data from an indirect treatment comparison.
The findings, presented at the European Academy of Neurology 2025 Congress in Helsinki, showed IMAAVY had comparable symptom relief onset at Week 1 and demonstrated greater or statistically significant improvement in MG-ADL scores versus other marketed FcRn blockers at several timepoints up to 24 weeks of treatment. This development adds to Johnson & Johnson’s robust pharmaceutical portfolio, which has helped drive the company’s impressive $89.3 billion in revenue over the last twelve months.
Population-adjusted comparisons showed significantly greater mean improvements in MG-ADL scores favoring IMAAVY over competitors at various timepoints between Weeks 8-24 for one comparator and Weeks 10-14 for another.
"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 Saiju Jacob, Professor at the University of Birmingham.
IMAAVY received FDA approval earlier this year for treatment of gMG in adults and pediatric patients 12 years and older who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. This represents the broadest approved patient population among gMG treatments.
Unlike cyclic therapies requiring clinical evaluation and symptom relapse before subsequent treatment cycles, IMAAVY follows a biweekly dosing regimen that may offer more predictable scheduling for patients and healthcare providers.
Johnson & Johnson submitted a Marketing Authorisation Application to the European Medicines Agency for nipocalimab in gMG in September 2024.
The indirect treatment comparison was funded by Janssen Research & Development, LLC, a Johnson & Johnson company, and used data from published registrational trials of IMAAVY and comparator FcRn blockers.
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