AMSTERDAM (dpa-AFX) - argenx SE (ARGX) reported that the pivotal ADAPT SERON study of VYVGART (IV: efgartigimod alfa-fcab) successfully met its primary endpoint. The study demonstrated a statistically significant and clinically meaningful improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living) total score among AChR-Ab seronegative gMG patients treated with VYVGART compared to placebo.
The company said it plans to submit an sBLA to the U.S. FDA seeking expansion of the VYVGART label to include adult AChR-Ab seronegative gMG patients across all three subtypes - MuSK+, LRP4+, triple seronegative.
According to the company, VYVGART was well tolerated and safe across AChR-Ab seronegative subtypes and consistent with the established safety profile in patients with AChR-Ab seropositive gMG and other indications. No new safety concerns were identified.
The Phase 3 ADAPT SERON study was a randomized, double-blind, placebo-controlled, multi-center study evaluating the safety and efficacy of efgartigimod in adults with AChR-Ab seronegative gMG (n=119) across North America, Europe, China, and the Middle East.
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