New York, May 08, 2026 (GLOBE NEWSWIRE) — The Muscular Dystrophy Association (MDA) today welcomed the U.S. Food and Drug Administration’s (FDA) approval for label expansion of VYVGART® (efgartigimod alfa-fcab) and VYVGART Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc) for all serotypes of adult patients living with generalized myasthenia gravis (gMG), including anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative – who historically have faced limited or no FDA-approved treatment options specific to their subtype. It will be marketed in the U.S. by argenx, read their press release here.
“People living with seronegative generalized myasthenia gravis often face a longer, more complicated journey to diagnosis and treatment,” said Angela Lek, PhD, Chief Research Officer at the Muscular Dystrophy Association. “The FDA’s approval reflects meaningful progress for a community that has historically had limited, targeted treatment options. Expanding treatment options is essential to improving quality of life and reducing the daily burden of this unpredictable disease.”
Presented in a poster at the 2026 MDA Clinical & Scientific Conference, the approval is supported by data from the Phase 3 ADAPT SERON study, a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of VYVGART in adults with gMG who do not have detectable anti-acetylcholine receptor antibodies (AChR-Ab) across three serotypes. The study met its primary endpoint, demonstrating clinically meaningful improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score compared to placebo at four weeks. Improvements were observed across subgroups, including anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative participants. The safety profile was consistent with previously reported data, with no new safety concerns identified.
About Generalized Myasthenia Gravis
Generalized myasthenia gravis is a rare, chronic autoimmune neuromuscular disease that disrupts communication between nerves and muscles, leading to fluctuating muscle weakness that can affect speaking, swallowing, breathing, and limb strength. While the majority of people with gMG test positive for AChR antibodies, approximately 20% are considered seronegative for AChR antibodies and may have other or no detectable antibodies, contributing to significant unmet medical need.
“For people living with myasthenia gravis, uncertainty is part of everyday life—uncertainty about symptoms, treatment response, and about what options are available,” said Carol Alvarez, MDA Ambassador, who lives with myasthenia gravis. “Hearing that the FDA has approved a therapy specifically studied in people living with MG gives our community hope that we are being seen and that progress is continuing.”
The MDA supports multidisciplinary care for families through the nationwide network of MDA Care Centers, many of which supported clinical trials of this therapy. MDA remains committed to advancing research, accelerating access to treatments, and ensuring that families living with myasthenia gravis have the resources and support they need. As part of its mission, MDA provides education, advocacy, clinical care support, and funding for groundbreaking research across more than 300 neuromuscular diseases, including more than $57 million invested in myasthenia gravis research.
“Patients with seronegative generalized myasthenia gravis have historically had limited treatment options, and many clinical trials have excluded them,” said Tahseen Mozaffar, MD, Director of the UCI Health ALS & Neuromuscular Center, an MDA Care Center. “Having a therapy like VYVGART studied for this population is important because it may offer improvements in day-to-day activities, reduce overall disease burden, and help patients be more functional and productive.”
Watch Dr. Mozaffar video here.
Community Education
The neuromuscular community is invited to attend a free MDA Virtual Learning Series: Spotlight on Myasthenia Gravis on Wednesday, June 17 from 2:00-6:00 p.m. ET. Speakers will include Gil Wolfe, MD, FAAN from the University of Buffalo SUNY and Michael K. Hehir, MD from the University of Vermont and more. Topics will include navigating a new diagnosis, understanding current standards of care and emerging treatments, as well as managing fatigue and maintaining independence. Register here.
Support and Guidance for Families
For more information on myasthenia gravis, including guidance and ongoing support for families and medical professionals, contact the MDA Resource Center by phone 1-833-ASK-MDA1 (1-833-275-6321) or email [email protected].
Media inquiries, contact [email protected].
About Muscular Dystrophy Association
Muscular Dystrophy Association (MDA) has been at the center of progress for people living with muscular dystrophy, ALS, and over 300 other neuromuscular conditions for 75 years. We unite researchers, clinicians, advocates, and families to speed the pace of discovery, improve access to expert care, and ensure inclusion in every aspect of life. Our mission is simple: give the people we serve the tools and opportunities to live longer, more independent lives. To learn more visit mda.org. Follow MDA on social media on Instagram, Facebook, X, Threads, Bluesky, TikTok, LinkedIn, and YouTube.
- FDA Approves Label Expansion for generalized myasthenia gravis