Halozyme’s Vyvgart SC receives European Commission approval

Halozyme Therapeutics announced that argenx received European Commission – EC – approval of Vyvgart co-formulated with Enhanze for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive. The European approval of Vyvgart SC provides the option for patient self-administration. The EC approval is applicable to all 27 European Union Member States plus Iceland, Norway and Liechtenstein. Vyvgart SC 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. Vyvgart SC was approved by the FDA in June and is marketed as Vyvgart Hytrulo.