Research & Development
Argenx's VYVGART SC co-formulated with ENHANZE receives EC approval to treat myasthenia gravis
17 November 2023 -

Halozyme Therapeutics, Inc. (NASDAQ: HALO), a US-based biopharmaceutical company, announced on Thursday that its licensee argenx has received approval from the European Commission (EC) for VYVGART SC (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with Halozyme's ENHANZE for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

The approval provides the option for patient self-administration and is applicable to all 27 European Union Member States and 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 (rHuPH20), Halozyme's ENHANZE drug delivery technology to facilitate subcutaneous delivery of biologics. It received approved by the US Food and Drug Administration in June 2023 and is marketed as VYVGART Hytrulo.