New Label Expansion in Generalized Myasthenia Gravis - Takeaways - MDSpire
Coming Soon: Introducing MDSpire News. Learn more
Conexiant’s news site is now MDSpire News. Learn more

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

Share

  • 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

Related Content

FDA approves first therapy for Alexander disease

The antisense oligonucleotide reduces production of the abnormal protein that accumulates in supportive cells in the brain.

International Consensus on the Evaluation and Management of : Results From a Modified Delphi Survey

Hypothalamic hamartomas (HH) are rare developmental brain lesions frequently associated with medically refractory epilepsy and complex neurobehavioral, cognitive and endocrine comorbidities.

  • by

  • August 14, 2026

  • 2 min
FDA approves gene therapy for MPS IIIA

The one-time intravenous treatment uses adeno-associated virus serotype 9 to deliver a functional copy of the SGSH gene.