Argenx Says FDA Approves Vyvgart Hytrulo Injection to Treat Neuromuscular Disease gMG
By Stephen Nakrosis
Argenx said Tuesday it received Food and Drug Administration approval for its Vyvgart Hytrulo injection to treat certain adult patients with generalized myasthenia gravis.
The National Institutes of Health said generalized myasthenia gravis, or gMG, is a chronic autoimmune, neuromuscular disease that can weaken skeletal muscles.
Argenx said its treatment is the first FDA-approved subcutaneous injectable for gMG. The treatment is for adult patients who are anti-acetylcholine receptor antibody positive, which represents about 85% of the total gMG population, according to the company.
The treatment is meant to be administered by a healthcare professional as a single injection once weekly injections for four weeks, argenx said.
Vyvgart Hytrulo is expected to be available for patients in the U.S. in July.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
June 20, 2023 18:54 ET (22:54 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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