Halozyme Announces argenx Received European Commission Approval for VYVGART® Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Rhea-AI Summary

Halozyme Therapeutics announced that argenx received European Commission approval for VYVGART with ENHANZE for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. The subcutaneous injection, available as a vial or prefilled syringe, is approved for patients previously treated with corticosteroids or immunoglobulins. VYVGART is notable as the first targeted IgG Fc-antibody fragment for CIDP and represents the first new treatment mechanism in over 30 years. The approval, based on the ADHERE clinical trial results, covers all 27 EU Member States plus Iceland, Norway, and Liechtenstein. This development marks a significant milestone in Halozyme's partnership with argenx and supports the company's growth strategy through expanded European market access.

Positive

• First novel treatment mechanism for CIDP in over 30 years, demonstrating innovation and market leadership
• Expands market access to all 27 EU countries plus Iceland, Norway, and Liechtenstein
• Strengthens partnership with argenx and supports Halozyme's growth strategy
• Offers convenient administration options through vial or prefilled syringe delivery

Negative

• None.

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 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today 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.

"We are pleased to announce the European Commission approval of the subcutaneous injection of VYVGART, which is co-formulated with our ENHANZE drug delivery technology for use in CIDP patients. This marks another milestone in our partnership with argenx and the expansion of access to Europe is another catalyst supporting our growth," said Dr. Helen Torley, president and chief executive officer of Halozyme.

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.

About Halozyme

Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.

Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate  of Viatris Inc.

Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.

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

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and broadening the treatment options for the indication referred to in this press release.  Forward-looking statements may also include statements regarding potential growth catalysts and opportunities driven by the product development and commercialization efforts of Halozyme's ENHANZE^® partners.  These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning unexpected results or delays in the timing of the Halozyme's expected growth catalysts or in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Contacts:

Tram Bui
VP, Investor Relations and Corporate Communications
609-333-7668
tbui@halozyme.com

Sydney Charlton
Teneo
917-972-8407 
sydney.charlton@teneo.com

 

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SOURCE Halozyme Therapeutics, Inc.

FAQ

What is the significance of VYVGART's EU approval for Halozyme (HALO)?

The EU approval represents a significant milestone for Halozyme, expanding their ENHANZE technology's market reach and strengthening their partnership with argenx, supporting company growth through increased European market access.

What makes VYVGART unique in CIDP treatment?

VYVGART is the first targeted IgG Fc-antibody fragment for CIDP and represents the first novel mechanism of action for CIDP treatment in more than 30 years.

Which countries are covered by the European Commission approval for VYVGART?

The approval covers all 27 European Union Member States, plus Iceland, Norway, and Liechtenstein.

How is VYVGART administered to CIDP patients?

VYVGART is administered as a subcutaneous injection and is available in either a vial or prefilled syringe format, which can be administered by a patient, caregiver, or healthcare professional.

What patient population is VYVGART approved for in the EU?

VYVGART is approved for adult patients with progressive or relapsing active CIDP who have received prior treatment with corticosteroids or immunoglobulins.