FDA Approves Label Expansion For Argenx Treatment of Autoimmune Disease

Dow Jones

May 09

By Christopher Kuo

Argenx SE said the Food and Drug Administration approved a label expansion for Vyvgart and Vyvgart Hytrulo, the company's treatments for a rare, chronic autoimmune disorder known as generalized myasthenia gravis.

The approved supplemental Biologics License Application expands Vyvgart's indication to include all serotypes of adult patients living with generalized myasthenia gravis, a disease that can result in debilitating and life-threatening muscle weakness, the company said Friday.

The approval is based on data from the company's Phase 3 study, in which patients treated with Vyvgart showed rapid and sustained improvements in their disease symptoms, the company said.

Write to Christopher Kuo at chris.kuo@wsj.com

(END) Dow Jones Newswires

May 08, 2026 17:40 ET (21:40 GMT)

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