New Label Expansion in Generalized Myasthenia Gravis - Takeaways - MDSpire

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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  • 1

    The FDA expanded the indication for efgartigimod to include all adults with generalized myasthenia gravis, regardless of antibody status.

  • 2

    The approval encompasses patients who are AChR-Ab positive, MuSK-Ab positive, LRP4-Ab positive, and triple seronegative.

  • 3

    The Phase 3 ADAPT SERON trial demonstrated significant improvement in MG-ADL scores for patients treated with efgartigimod compared to placebo.

  • 4

    Efgartigimod showed a mean 3.35-point improvement in MG-ADL total score at week 4, with benefits observed across various antibody subgroups.

  • 5

    The treatment was well tolerated, with common side effects including respiratory infections, headaches, and injection-site reactions.

Original Source(s)

New Label Expansion in Generalized Myasthenia Gravis

  • by Kathryn Wighton

  • May 11, 2026

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