Halozyme Therapeutics, Inc. Announces Argenx Received European Commission Approval for VYVGART® Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy

Published: 2025-06-20 14:05:24 ET HALO

Published on 06/20/2025 at 14:05

Halozyme Therapeutics, Inc. announced that argenx received European Commission (EC) approval of VYVGART® 1000mg (efgartigimod alfa) developed with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins. VYVGART is the first and only targeted IgG Fc-antibody fragment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and the first novel mechanism of action for CIDP treatment in more than 30 years. The EC decision is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date.

For more information on the study and its findings, please view argenx's press release issued on June 20, 2025. The approval by the EC is valid in all 27 European Union (EU) Member States, as well as Iceland, Norway and Liechtenstein.