Halozyme Therapeutics, Inc. (NASDAQ: HALO) (“Halozyme”) today announced that argenx received European Commission (EC) approval of VYVGART® SC (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with ENHANZE® for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) 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.
“We are excited that the European approval of VYVGART SC for patients with generalized myasthenia gravis follows closely on the U.S. approval in June of this year, resulting in many new gMG patients having the option to receive their treatment as a 30-90 second subcutaneous administration,” said Dr. Helen Torley, president and chief executive officer of Halozyme.
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. VYVGART® SC was approved by the U.S. Food and Drug Administration in June 2023 and is marketed as VYVGART® Hytrulo.
The EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and is based on positive results from the Phase 3 ADAPT-SC study. ADAPT-SC established the efficacy of VYVGART® SC by demonstrating a reduction in anti-AChR antibody levels comparable to VYVGART® IV in adult gMG patients.