New Label Expansion in Generalized Myasthenia Gravis - Takeaways - 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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    FDA expands VYVGART approval for all adults with gMG.

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    Includes seronegative patients.

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    Based on ADAPT SERON trial findings.

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    Significant improvement in MG-ADL scores at week

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    Safety profile aligns with previous uses of VYVGART.

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    Common side effects: respiratory infections, headaches.

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    Importance for the 20% of patients who are seronegative.

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    Addresses challenges in diagnosis and management.

Original Source(s)

New Label Expansion in Generalized Myasthenia Gravis

  • by Kathryn Wighton

  • May 11, 2026

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