Halozyme Announces argenx Receives FDA Approval for VYVGART® Hytrulo Co-Formulated with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy

Rhea-AI Summary

Halozyme Therapeutics announced that argenx received FDA approval for VYVGART® Hytrulo, co-formulated with Halozyme's ENHANZE®, for treating chronic inflammatory demyelinating polyneuropathy (CIDP). This is the first neonatal Fc receptor blocker approved as a subcutaneous injection for CIDP. The ADHERE study, the largest clinical trial on CIDP, showed a 69% clinical improvement rate and a 61% reduction in relapse risk compared to placebo. This is the second FDA-approved indication for VYVGART® Hytrulo with ENHANZE®, the first being for generalized myasthenia gravis. The safety profile remained generally consistent with previous studies.

Positive

• FDA approval for VYVGART® Hytrulo with ENHANZE® for CIDP treatment.
• ADHERE study shows 69% clinical improvement rate and 61% reduction in relapse risk.
• Second FDA-approved indication for VYVGART® Hytrulo with ENHANZE®.

Negative

• None.

Insights

Medical Research Analyst

The FDA approval for VYVGART® Hytrulo, which includes the ENHANZE® technology, marks a significant step forward in the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). This novel injection, designed for subcutaneous delivery, ensures a quick administration of just 30 to 90 seconds weekly, a substantial improvement over existing treatment methods. The pivotal data from the ADHERE trial highlights that 69% of patients showed clinical improvement and the primary endpoint indicated a remarkable 61% reduction in the risk of relapse compared to placebo. This strongly supports the efficacy of the drug. For patients, this means a new, more convenient treatment option, potentially improving adherence and quality of life. However, long-term safety and effectiveness will need continuous monitoring to confirm these benefits in broader, real-world settings.

Financial Analyst

The FDA approval of VYVGART® Hytrulo for CIDP is likely to positively influence Halozyme's financial outlook. This approval provides a new revenue stream, reducing reliance on their existing portfolio. Given the rarity of CIDP and the lack of new treatments over the past three decades, the demand for an effective and convenient therapy is likely to be high. The clinical data suggests strong efficacy, which could drive rapid adoption. From a financial perspective, the broad endorsement seen by the 99% participation rate in the ADHERE study's open-label extension underscores patient and clinician confidence. Investors can anticipate increased sales and market penetration, but should also remain cautious about potential pricing pressures and competition in the rare disease market.

Market Research Analyst

The market implications of the FDA approval for VYVGART® Hytrulo with ENHANZE® are substantial. This product not only addresses a significant unmet need in the CIDP therapeutic landscape but also leverages Halozyme's proprietary ENHANZE® technology, potentially setting a new market standard for subcutaneous injections. The convenience of a weekly, quick administration is a strong selling point, likely to resonate well with both patients and healthcare providers. This approval could strengthen Halozyme's market position, paving the way for further innovation in drug delivery systems. Nonetheless, market penetration will depend on strategic pricing and effective communication of clinical benefits to healthcare providers and patients alike.

VYVGART® Hytrulo is the first and only neonatal Fc receptor (FcRn) blocker that is delivered as a subcutaneous injection, approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP)

CIDP is the second FDA-approved indication for VYVGART® Hytrulo with ENHANZE®

SAN DIEGO, June 21, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that argenx received U.S. Food and Drug Administration (FDA) approval for VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP).

VYVGART® Hytrulo for CIDP is FDA-approved as a once weekly 30-to-90 second subcutaneous (SC) injection. This approval also represents the second FDA-approved indication for VYVGART® Hytrulo with ENHANZE®.

"With this approval, CIDP patients in the U.S. will have access to the first novel mechanism of action to treat CIDP in 30 years, which lessens the burden of treatment as a 30 to 90 second weekly SC injection," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We look forward to continuing to support argenx with our ENHANZE technology that has enabled improved treatment options that provide meaningful benefits for patients and healthcare providers."

The FDA approval is based on the ADHERE study, the largest clinical trial to date studying CIDP. In the ADHERE study, 69% (221/322) of patients treated with VYVGART® Hytrulo, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function and strength. ADHERE met its primary endpoint (p<0.0001) demonstrating a 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo. 99% of trial participants elected to participate in the ADHERE open-label extension. The safety results were generally consistent with the known safety profile of VYVGART® in previous clinical studies and real-world use.

VYVGART® Hytrulo is also approved in the U.S. for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive.

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 reducing treatment burden for patients. Having touched more than 800,000 patient lives in post-marketing use in seven commercialized products 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 several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.

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 in this press release include forward-looking statements including, without limitation, statements concerning the Company's ENHANZE® drug delivery technology including the possible 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, facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery and certain other benefits of ENHANZE® including lowering the treatment burden for patients. Forward-looking statements regarding the Company's ENHANZE® business may include potential growth driven by our partners' development and commercialization efforts (including anticipated regulatory submissions, PDUFA dates, potential regulatory approvals, indications and product launches). These forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company 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
609-359-3016
tbui@halozyme.com

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

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SOURCE Halozyme Therapeutics, Inc.

FAQ

What is VYVGART® Hytrulo approved for?

VYVGART® Hytrulo is approved for treating chronic inflammatory demyelinating polyneuropathy (CIDP) and generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive.

When did VYVGART® Hytrulo receive FDA approval for CIDP?

VYVGART® Hytrulo received FDA approval for CIDP on June 21, 2024.

What is the significance of the ADHERE study for VYVGART® Hytrulo?

The ADHERE study is the largest clinical trial for CIDP and showed a 69% clinical improvement rate and a 61% reduction in relapse risk for patients treated with VYVGART® Hytrulo.

How is VYVGART® Hytrulo administered for CIDP?

VYVGART® Hytrulo is administered as a once weekly 30-to-90 second subcutaneous injection for CIDP.

What role does Halozyme's ENHANZE® technology play in VYVGART® Hytrulo?

Halozyme's ENHANZE® technology, a recombinant human hyaluronidase enzyme, is co-formulated with VYVGART® Hytrulo to improve treatment options for patients.