Halozyme Announces argenx Received Positive CHMP Opinion for VYVGART® (efgartigimod alfa) Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Rhea-AI Summary

Halozyme Therapeutics (NASDAQ: HALO) announced that argenx received a positive CHMP opinion recommending European Commission approval for VYVGART® with ENHANZE® for chronic inflammatory demyelinating polyneuropathy (CIDP) treatment. The subcutaneous injection, available as a vial or prefilled syringe, is designed for adult patients with progressive or relapsing active CIDP after prior treatment with corticosteroids or immunoglobulins.

VYVGART represents the first targeted IgG Fc-antibody fragment for CIDP and the first novel mechanism of action in over 30 years. The recommendation is based on the ADHERE clinical trial, the largest CIDP patient study to date. The European Commission's decision, expected within two months, will apply to all 27 EU Member States plus Iceland, Norway, and Liechtenstein.

Positive

• First novel CIDP treatment mechanism in 30+ years, indicating potential market leadership
• Positive CHMP opinion paves way for approval in 30 European countries
• Flexible administration options (vial/prefilled syringe) enhance market potential
• Backed by largest CIDP patient study to date (ADHERE trial)

Negative

• Final EC approval still pending
• Market entry dependent on successful European Commission decision

Insights

Biotechnology Industry Analyst

CHMP recommends EU approval of VYVGART with Halozyme's ENHANZE technology for CIDP, expanding commercial potential in 30 European countries.

This positive CHMP opinion represents a significant milestone for Halozyme's proprietary ENHANZE drug delivery technology platform. argenx's VYVGART subcutaneous injection, which incorporates Halozyme's recombinant human hyaluronidase enzyme (rHuPH20), has been recommended for approval in the EU for treating chronic inflammatory demyelinating polyneuropathy (CIDP).

The strategic importance of this development cannot be overstated. VYVGART with ENHANZE would be the first novel mechanism of action for CIDP treatment in more than 30 years, positioning it as a potentially groundbreaking therapy in this indication. The subcutaneous formulation enables self-administration by patients or caregivers, providing a significant convenience advantage over traditional treatments.

From a regulatory perspective, CHMP positive opinions typically lead to European Commission approval, which is expected within approximately two months. This would expand Halozyme's commercial footprint across 30 European countries (27 EU Member States plus Iceland, Norway, and Liechtenstein).

This recommendation validates Halozyme's business model of partnering its proprietary drug delivery technology with innovative therapeutics. CIDP is a chronic condition requiring ongoing treatment, suggesting potential for sustained utilization of ENHANZE technology if approved. The ADHERE clinical trial, described as the largest study of CIDP patients to date, provides robust clinical evidence supporting this application.

While the final EC decision is still pending, this regulatory progress strengthens Halozyme's position as a leading provider of subcutaneous drug delivery technology and expands the potential commercial applications of its ENHANZE platform.

European Commission (EC) decision on marketing authorization application expected within approximately two months

SAN DIEGO, April 28, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that argenx received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending 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.

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

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 delighted that the subcutaneous injection of VYVGART® co-formulated with our ENHANZE drug delivery technology, has been recommended for approval in the European Union. The positive CHMP opinion moves argenx closer to offering patients throughout Europe a groundbreaking new treatment option. We are proud to support argenx achieve their vision of developing innovative, targeted treatments for patients with rare and severe autoimmune diseases," said Dr. Helen Torley, president and chief executive officer of Halozyme.

The CHMP recommendation is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date. For more information on the CHMP recommendation, and the ADHERE study and its findings, please view argenx's press release issued on April 28, 2025.

The EC is expected to make a decision following CHMP recommendation and the decision will apply to all 27 European Union Member States, and also to 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 the product development efforts of Halozyme's ENHANZE® partner and the potential approval of an extension of marketing authorization for the subcutaneous formulation referred to in this press release and the timing of such potential approval. 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 whether the extension of marketing authorization for the subcutaneous formulation referred to in this press release is delayed or ultimately approved, unexpected results or delays 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

Samantha Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com 

 

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SOURCE Halozyme Therapeutics, Inc.

FAQ

What is the significance of VYVGART's CHMP recommendation for HALO stock?

The positive CHMP opinion for VYVGART with ENHANZE technology represents a significant milestone for Halozyme, potentially expanding their market presence in Europe and generating additional revenue through their drug delivery technology partnership with argenx.

When will the European Commission make a final decision on VYVGART with ENHANZE?

The European Commission is expected to make their final decision within approximately two months following the CHMP recommendation.

How is VYVGART with ENHANZE administered for CIDP treatment?

VYVGART with ENHANZE is administered as a subcutaneous injection, available in both vial and prefilled syringe forms, and can be administered by patients, caregivers, or healthcare professionals.

What makes VYVGART unique in the CIDP treatment landscape?

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.