Core Insights - Argenx SE presented new data on the efficacy and safety of VYVGART for generalized myasthenia gravis (gMG) at the 2025 AANEM and MGFA meetings, highlighting its potential to improve patient outcomes across various gMG populations [1][2][3] Efficacy and Safety Data - The pivotal Phase 3 ADAPT SERON trial demonstrated that AChR-Ab seronegative gMG patients treated with VYVGART achieved a statistically significant improvement in MG-ADL total score compared to placebo, with a mean change of 3.35 points at week 4 [6] - Approximately 60% of VYVGART-treated gMG patients achieved minimal symptom expression (MSE), with 88% sustaining MSE for at least 4 weeks [5][6] - Real-world data indicated that over 70% of patients treated with VYVGART significantly reduced glucocorticoid use while maintaining clinical benefits [5][15] Treatment Impact - VYVGART is positioned as a targeted, effective, and safe treatment for gMG patients, regardless of autoantibody status, with ongoing studies contributing to redefining treatment standards [4][7] - The ADAPT Jr study showed that VYVGART improved outcomes in adolescents with gMG, addressing a high unmet need in this population [8] Regulatory Plans - Argenx plans to share the ADAPT SERON trial results with the U.S. FDA to seek an expansion of the VYVGART label to include adult AChR-Ab seronegative gMG patients across all subtypes [7] Long-term Outcomes - Long-term treatment with VYVGART was associated with substantial reductions in oral glucocorticoid use, with 72.5% of patients achieving meaningful tapering and an average daily dose reduction of over 50% after 18 months [15][26]
argenx Presents New Data at AANEM and MGFA Highlighting the Strength and Broad Benefit of VYVGART for Myasthenia Gravis Patients
