Pharma Focus America

FDA Approves argenx's VYVGART Hytrulo: Subcutaneous Treatment for Generalized Myasthenia Gravis

argenx SE, a global immunology company focused on improving the lives of individuals with severe autoimmune diseases, has announced the approval of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) by the U.S. Food and Drug Administration (FDA). VYVGART Hytrulo is a subcutaneous injection designed for the treatment of generalized myasthenia gravis (gMG) in adult patients who test positive for anti-acetylcholine receptor (AChR) antibodies. This patient group represents approximately 85% of the total gMG population.

VYVGART Hytrulo combines efgartigimod alfa, a human IgG1 antibody fragment marketed as VYVGART for intravenous use, with recombinant human hyaluronidase PH20 (rHuPH20) using Halozyme's ENHANZE® drug delivery technology, which facilitates subcutaneous administration of biologics. The treatment is administered as a single injection (1,008 mg fixed dose) over 30-90 seconds by a healthcare professional once weekly for four weeks.

The approval of VYVGART Hytrulo is a significant milestone for argenx in its mission to redefine the management of gMG and improve patient outcomes. This development also demonstrates the company's dedication to the gMG community by providing additional treatment options and administration flexibility. VYVGART Hytrulo is expected to be available to patients in the United States from July 2023 onward. The pricing of VYVGART Hytrulo will be set at parity with VYVGART based on net annual revenue.To support patient access and provide a personalized treatment experience, argenx offers the My VYVGART Path program. This program provides resources including disease and product education, access support, benefits verification, and financial assistance programs for eligible patients.

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