argenx | argenx Announces U.S. FDA Approval Expanding VYVGART and VYVGART Hytrulo for Use in All Adult Patients Living with gMG
We are pleased to share an important update from argenx regarding the treatment landscape for generalized myasthenia gravis (gMG).
The U.S. Food and Drug Administration (FDA) has approved a label expansion for VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) to include all adult patients living with gMG, regardless of antibody status. This means the therapies are now approved for patients who are anti-AChR antibody positive, anti-MuSK antibody positive, anti-LRP4 antibody positive, as well as those who are triple seronegative.
This approval is based on results from the Phase 3 ADAPT SERON study, which demonstrated rapid, statistically significant, and clinically meaningful improvements in daily functioning compared to placebo. Improvements were observed across symptoms impacting daily life, including speech, vision, swallowing, and physical function.
This milestone is particularly meaningful for individuals who do not have detectable AChR antibodies—a community that has historically faced limited inclusion in clinical research and fewer targeted treatment options.
We recognize the important role you play in supporting individuals living with MG and are committed to keeping you informed as new developments emerge.
