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
05-08-26 1755ET
