(Reuters) – The U.S. Food and Drug Administration has approved Argenx SE’s under-the-skin injection for the treatment of a muscle-weakening genetic disease called generalized myasthenia gravis, the company said on Tuesday.
The regulator had approved an intravenous version of the drug in 2021, but the company expects an under-the-skin version to offer more convenient dosing than infusion into the veins.
Generalized myasthenia gravis (gMG) is a chronic neuromuscular disease caused by an abnormal immune reaction that weakens the muscles in different parts of the body.
The drug, to be sold under the brand name Vyvgart Hytrulo, uses the active ingredient efgartigimod along with Halozyme Therapeutics’ drug delivery system.
Argenx’s other formulation of efgartigimod is approved under the brand name Vyvgart and generated more than $400 million in global sales last year.
(Reporting by Aditya Samal, Leroy Leo and Raghav Mahobe in Bengaluru; Editing by Shilpi Majumdar and Devika Syamnath)
