SPRING HOUSE, PA — Johnson & Johnson presented new data on its investigational treatment, nipocalimab, at the 2025 American Academy of Neurology (AAN) Annual Meeting, providing insight into its potential to address generalized myasthenia gravis (gMG). Among 12 abstracts shared, the company highlighted pivotal Phase 3 study findings and real-world data underscoring the treatment’s promise and the ongoing unmet needs in gMG care.
Key findings from the Vivacity-MG3 study revealed that treatment with nipocalimab produced significant improvements in disease control in antibody-positive adult patients, including those with anti-AChR, anti-MuSK, and anti-LRP4 markers. The clinician-assessed Quantitative Myasthenia Gravis (QMG) score showed sustained muscle strength improvements, with data from an open-label extension study confirming the treatment’s long-term safety and efficacy.
Real-world evidence further emphasized the challenges faced by gMG patients, particularly pregnant women. The findings echoed the urgency for new therapies to address disease progression during pregnancy, which remains an underserved area. Additionally, data on oral corticosteroid use in gMG highlighted the need for therapies with improved safety profiles to mitigate the adverse effects associated with long-term steroid reliance.
The significance of these findings is amplified by the FDA’s decision to grant Priority Review to the Biologics License Application (BLA) for nipocalimab in August 2024. This designation reflects the urgency and potential impact of the treatment on patients living with gMG.
The data presented at the AAN meeting also shed light on socioeconomic factors influencing access to care, particularly the variability in antibody testing practices, which left some patients without a complete diagnosis. With enhanced testing and targeted treatment options, the standard of care has the potential to advance significantly.
By addressing both clinical outcomes and broader healthcare disparities, Johnson & Johnson’s research on nipocalimab aims to pave the way for more effective and equitable care in gMG. The company’s presentations at AAN reiterate its commitment to expanding therapeutic options for this challenging autoimmune disease.
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