Trump announces trade deal with EU following months of negotiations
SPRING HOUSE, Pa. - 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.
This article is based on a press release statement from Johnson & Johnson.
In other recent news, Johnson & Johnson presented promising Phase 1b data for its experimental dual-targeting CAR T-cell therapy, showing high response rates in patients with relapsed or refractory large B-cell lymphoma. The therapy achieved complete response rates of 75-80% among evaluable patients at the recommended Phase 2 dose, with a favorable safety profile. Additionally, Johnson & Johnson reported positive results for its investigational drug bleximenib, which showed significant antileukemic activity in combination with venetoclax and azacitidine for treating acute myeloid leukemia, achieving an overall response rate of 82% in relapsed or refractory cases. In another development, Johnson & Johnson’s Tremfya demonstrated significant ability to inhibit joint structural damage progression in patients with psoriatic arthritis, reducing progression by two and a half times compared to placebo. Furthermore, Daniel Pinto, President of JPMorgan Chase, has been elected to Johnson & Johnson’s Board of Directors, bringing over three decades of financial expertise. Lastly, new data from Johnson & Johnson’s CARTITUDE-1 study showed that 33% of patients with relapsed or refractory multiple myeloma treated with CARVYKTI experienced progression-free survival for five years or longer. These recent developments highlight Johnson & Johnson’s ongoing efforts in advancing innovative treatments across various medical conditions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.