Argenx has announced that the US Food and Drug Administration has accepted for priority review a supplemental biologics licence application for VYVGART for adults with acetylcholine receptor antibody seronegative generalised myasthenia gravis. The agency has set a Prescription Drug User Fee Act target action date of 10 May 2026.
Luc Truyen, Chief Medical Officer at argenx, said: “Patients living with seronegative gMG continue to face limited treatment options and there remains a significant need to meaningfully improve their lives. The FDA’s acceptance of our sBLA with Priority Review status reflects the potential of VYVGART to address this need.”
Truyen added: “This development brings us closer to expanding the use of VYVGART in a broad spectrum of patients with myasthenia gravis. We look forward to continuing our dialogue with the FDA as they review our application.”
The application is supported by results from the phase 3 ADAPT SERON study, that evaluated VYVGART in adults with seronegative gMG across MuSK+, LRP4+ and triple seronegative subtypes. The trial met its primary endpoint, showing a statistically significant improvement in Myasthenia Gravis Activities of Daily Living total score compared with placebo after four weeks.
Across the overall population, patients treated with VYVGART achieved a mean 3.35‑point improvement in MG‑ADL total score at week 4. Improvements in MG‑ADL and Quantitative Myasthenia Gravis scores were also observed across subsequent treatment cycles and in all subgroups.
The company reported that VYVGART was well tolerated, with a safety profile consistent with its established use in acetylcholine receptor antibody seropositive gMG and other indications, and no new safety concerns identified.
