argenx Gains EU Approval for VYVGART® Subcutaneous Injection with ENHANZE® for CIDP

Halozyme Therapeutics, Inc., a prominent biopharmaceutical company, has announced that argenx has successfully secured approval from the European Commission for VYVGART® 1000mg. This drug, developed using Halozyme's proprietary ENHANZE® technology, is designed for subcutaneous administration as a standalone treatment for adult patients suffering from progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP). This approval is specifically for patients who have previously undergone treatment with corticosteroids or immunoglobulins. The availability of VYVGART® as a subcutaneous injection offers flexible administration options, as it can be delivered through a vial or a prefilled syringe by the patients themselves, caregivers, or healthcare professionals.

This significant development marks a milestone in CIDP treatment, as VYVGART® is the first and only targeted IgG Fc-antibody fragment approved for this condition. Notably, it introduces a novel mechanism of action for CIDP treatment that hasn't been seen in over three decades. Dr. Helen Torley, President and CEO of Halozyme, expressed satisfaction with the approval, highlighting it as an important achievement in their collaboration with argenx. She emphasized that expanding access to Europe is a catalyst for growth, reflecting the company's dedication to enhancing therapeutic solutions internationally.

The European Commission's decision is rooted in the promising outcomes from the ADHERE clinical trial, recognized as the largest study involving CIDP patients to date. These findings affirm the effectiveness and safety of VYVGART® for the indicated patient population. This approval extends across all 27 EU Member States, alongside Iceland, Norway, and Liechtenstein, indicating a broad acceptance within the region.

Halozyme, the innovator behind ENHANZE® drug delivery technology, utilizes a proprietary enzyme known as rHuPH20. This technology aims to improve patient experiences by facilitating rapid subcutaneous delivery of injected medications and fluids. By reducing treatment burdens, ENHANZE® aims to enhance the patient experience significantly. Halozyme's groundbreaking solution has benefited over one million patients through post-marketing usage in ten commercialized products across more than 100 global markets. The technology has been licensed to top pharmaceutical and biotechnology companies such as Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, and Acumen Pharmaceuticals.

Beyond its licensing endeavors, Halozyme also focuses on developing, manufacturing, and commercializing drug-device combination products, either independently or through partnerships. These products leverage advanced auto-injector technologies designed to offer commercial and functional advantages, including enhanced convenience, reliability, and patient comfort. The company boasts two proprietary commercial products, Hylenex® and XYOSTED®, along with partnered products and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc.

Halozyme is headquartered in San Diego, California, with additional offices in Ewing, New Jersey, and Minnetonka, Minnesota, the latter also serving as its operations facility. This geographical spread facilitates its operations and collaborations across different regions, supporting its mission to advance patient care through innovative biopharmaceutical solutions.