New Label Expansion in Generalized Myasthenia Gravis

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

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.

1