Halozyme: argenx Receives European Commission Approval for Subcutaneous VYVGART® with ENHANZE® in CIDP

SC injection of VYVGART® is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional

SAN DIEGO, June 20, 2025 – Halozyme Therapeutics, Inc. (HALO), a company known for its innovative drug delivery technology, announced today that argenx has received European Commission (EC) approval for VYVGART® 1000mg (efgartigimod alfa). Developed with ENHANZE®, Halozyme’s proprietary recombinant human hyaluronidase enzyme (rHuPH20), the subcutaneous (SC) injection is approved as a monotherapy for adult patients battling chronic inflammatory demyelinating polyneuropathy (CIDP) who have previously undergone treatment with corticosteroids or immunoglobulins. This marks a pivotal moment in the treatment of CIDP.

VYVGART stands as both the first targeted IgG Fc-antibody fragment specifically for CIDP and the first novel mechanism of action introduced for this debilitating condition in over three decades. It highlights not only the advancement of medical science but also the potential for novel treatment approaches.

“We are thrilled with the European Commission’s approval of the subcutaneous injection of VYVGART, which utilizes our ENHANZE drug delivery technology for CIDP patients,” stated Dr. Helen Torley, president and chief executive officer of Halozyme. “This milestone in our partnership with argenx significantly expands access to the drug across Europe, further supporting our impressive growth trajectory.”

The EC’s decision is based on the positive data from the ADHERE clinical trial, currently the largest study conducted on CIDP patients. For an in-depth analysis of the study results, readers can refer to argenx’s press release released on June 20, 2025.

The approval by the EC is valid in all 27 European Union (EU) Member States, and extends to Iceland, Norway and Liechtenstein.

About Halozyme

Halozyme is a biopharmaceutical innovator focused on significantly improving patient experiences and outcomes for both novel and established therapies. The company is best known for its groundbreaking ENHANZE drug delivery technology, utilizing the proprietary enzyme rHuPH20. This technology enables the subcutaneous delivery of injected drugs and fluids, with the objective of delivering a better patient experience, via rapid absorption and a reduction in treatment burden. Having been used for over one million patients via ten commercialized products in at least one major region and over 100 global markets, Halozyme has partnered with numerous leading pharmaceutical and biotechnology players, including Roche, Pfizer, Takeda, and AbbVie, to name a few.

The company also develops, manufactures and commercializes proprietary drug-device combination products, often through partnerships, utilizing cutting-edge auto-injector systems. These are designed to deliver commercial advantages such as improved ease of use, reliability, and patient comfort and medication adherence. Halozyme currently lists Hylenex® and XYOSTED® as its proprietary commercial products, has partnered commercial products, and is engaged in ongoing product development programs.

Headquartered in San Diego, CA, Halozyme maintains offices in Ewing, NJ and Minnetonka, MN. The Minnetonka facility also functions as its primary operations center.

For more information, visit www.halozyme.com and connect with us on LinkedIn and Twitter.

Safe Harbor Statement

The forward-looking statements contained herein, including the potential impact of ENHANZE®, are subject to risks and uncertainties. Actual results could vary significantly due to factors such as, but not limited to, unforeseen delays; unexpected adverse events; and competitive market conditions. These and other factors are examined in detail in Halozyme’s SEC filings. Halozyme does not guarantee any updates to the present release, which focuses on circumstances at the time of its publication.