Halozyme says Argenx receives FDA approval for Vyvgart Hytrulo with Enhanze

Halozyme Therapeutics (HALO) announced that Argenx (ARGX) received U.S. Food and Drug Administration approval for VYVGART Hytrulo injection with ENHANZE for subcutaneous use for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive. VYVGART Hytrulo is a subcutaneous product combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART, and recombinant human hyaluronidase PH20, Halozyme’s ENHANZE drug delivery technology to facilitate subcutaneous delivery of biologics. The product is to be administered subcutaneously by a healthcare professional as a single injection over 30-90 seconds in cycles of once weekly injections for four weeks. “We are pleased that argenx has received FDA approval for the subcutaneous form of efgartigimod, which reinforces their commitment to the patient community with a broadening of treatment options that brings flexibility for patients,” said Dr. Helen Torley, president and chief executive officer of Halozyme. “We look forward to the multiple data readouts this year for subcutaneously administered efgartigimod in additional autoimmune conditions, with the potential to expand the number of approved indications and eligible patients.”