newsio aggregates and links to original sources. We do not own the original images or content. If you believe content infringes on intellectual property rights, contact us — it will be removed at first notice.
biotech/news//MarketScreener
The Food and Drug Administration approved a label expansion for Vyvgart.
The FDA approved a label expansion for Argenx's Vyvgart and Vyvgart Hytrulo treatments.
KEY POINTS
Vyvgart is now indicated for all serotypes of adult generalized myasthenia gravis patients.
The expanded approval is based on data from Argenx's Phase 3 clinical study.
Patients treated with Vyvgart in the study showed rapid and sustained symptom improvement.
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 [email protected]
(END) Dow Jones Newswires
05-08-26 1755ET