New Label Expansion in Generalized Myasthenia Gravis - Summary - MDSpire
FDA & Government News

New Label Expansion in Generalized Myasthenia Gravis

Phase 3 ADAPT SERON data supported efgartigimod use across antibody subtypes often underrepresented in trials.

  • By

  • Kathryn Wighton

  • May 11, 2026

  • 2 min

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The FDA has expanded the approval of efgartigimod alfa-fcab (VYVGART) and efgartigimod alfa with hyaluronidase-qvfc (VYVGART Hytrulo) to all adults with generalized myasthenia gravis (gMG), including those with various antibody statuses. The decision stems from the Phase 3 ADAPT SERON trial, which showed significant improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores among treated patients. This advancement addresses the challenges faced by the approximately 20% of gMG patients who are seronegative, enhancing treatment options for a previously underserved patient group.

Original Source(s)

New Label Expansion in Generalized Myasthenia Gravis

  • by Kathryn Wighton

  • May 11, 2026

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