The U.S. Food and Drug Administration has approved a label expansion for Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with (gMG). The expanded approval was granted to argenx.
The supplemental Biologics License Application expands Vyvgart’s indication for all serotypes of adult patients living with gMG, including anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
The approval is based on data from the Phase III ADAPT SERON study, in which participants treated with Vyvgart showed clinically meaningful improvements in disease activity and symptoms, including speech, vision, physical function, and swallowing.
Participants treated with Vyvgart achieved a statistically significant improvement in the Myasthenia Gravis Activities of Daily Living total score (the primary end point) compared with placebo at week 4. In addition, Vyvgart was well tolerated across serotypes, consistent with the established safety profile.
“For too long, gMG patients who do not have detectable AChR-Ab have been left behind,” Allison Foss, executive director of the Myasthenia Gravis Association, said in a statement. “This approval validates that gMG patients without AChR-Ab can benefit from a targeted treatment, bringing a sense of hope to thousands in our community.”
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