FDA expands Vyvgart, Vyvgart Hytrulo approval in adults with gMG

Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) are now approved in the U.S. to treat all adults with generalized myasthenia gravis (gMG), regardless of antibody status.

The U.S. Food and Drug Administration (FDA) initially approved Vyvgart in 2021 and Vyvgart Hytrulo in 2023 for adults with gMG who were positive for self-reactive antibodies against the acetylcholine receptor (AChR) protein, the most common type of MG-driving antibody. Vyvgart is administered directly into the bloodstream, while Vyvgart Hytrulo is given via under-the-skin injections.

Recommended Reading

May 6, 2026 News by Andrea Lobo

Vyvgart may offer IVIG alternative for people with hard-to-control gMG

Expanded label covers all adult gMG patients

Now, the FDA has expanded the label of both therapies to cover all adults with gMG, including patients with less-common MG-driving antibodies targeting the muscle-specific kinase (MuSK) protein or the low-density lipoprotein receptor-related protein 4 (LRP4). The expanded label also covers patients who are triple seronegative, meaning they test negative for antibodies against AChR, MuSK, and LRP4.

“Today’s approval means that all adult gMG patients, regardless of [antibody status], can now benefit from Vyvgart’s rapid onset, sustained disease control, and favorable safety profile,” Luc Truyen, MD, PhD, chief medical officer at Argenx, the company that sells Vyvgart, said in a company press release. “For clinicians, this simplifies treatment decisions, representing a major advancement in reaching as many patients living with gMG as possible.”

With this expansion, Vyvgart and Vyvgart Hytrulo are now the only FDA-approved treatments for all adults with gMG regardless of antibody status. Both therapies are given in treatment cycles that include once-weekly doses for four weeks.

Vyvgart Hytrulo is currently available as a prefilled syringe that can be self-administered by patients after training, and an autoinjector version is expected to launch next year.

The expanded approval was also welcomed by the Muscular Dystrophy Association (MDA), an organization that advocates for people with myasthenia gravis (MG) and a range of other neuromuscular diseases.

“People living with seronegative [non-AChR-related] generalized myasthenia gravis often face a longer, more complicated journey to diagnosis and treatment,” Angela Lek, PhD, MDA’s chief research officer, said in an association press release. “The FDA’s approval reflects meaningful progress for a community that has historically had limited, targeted treatment options.”

MG is an autoimmune disease in which the immune system disrupts communication between nerve and muscle cells, resulting in symptoms such as muscle weakness and fatigue. In many patients, this disruption is driven by self-reactive antibodies. In gMG, muscles throughout the body are affected.

Vyvgart is designed to block the activity of neonatal Fc receptor (FcRn), a protein that helps stabilize antibodies in the blood. By blocking FcRn, the therapy reduces circulating IgG autoantibodies, including those that can drive gMG.

ADAPT SERON supported expanded FDA approval

“Although many MG patients have detectable [anti-AChR antibodies], roughly 20% do not, making diagnosis and management especially difficult,” said James F. Howard Jr., MD, a professor of neurology at The University of North Carolina at Chapel Hill School of Medicine.

The expanded FDA approval was based on data from the Phase 3 ADAPT SERON clinical trial (NCT06298552), which tested Vyvgart against a placebo in 119 adults with gMG who were negative for anti-AChR antibodies.

Results showed Vyvgart led to a statistically significant improvement over placebo in MG-ADL total score, a measure of how MG affects daily activities, after four weeks. Improvements also were seen on other disease measures, and no new safety concerns were identified.

“Patients with seronegative generalized myasthenia gravis have historically had limited treatment options, and many clinical trials have excluded them,” said Tahseen Mozaffar, MD, the 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.”

Howard added that the expanded approval “enables healthcare providers to prescribe this targeted treatment more readily upon clinical diagnosis, irrespective of [antibody status].”

The MDA is hosting a free, virtual webinar, titled “Spotlight On: Myasthenia Gravis,” on June 17, from 2-6 p.m. ET, where MG experts will discuss MG diagnosis, fatigue and its management, and current and future treatments.