Halozyme Announces argenx Receives European Commission Approval of VYVGART® SC with ENHANZE® for Generalized Myasthenia Gravis

Rhea-AI Summary

Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced that argenx received European Commission approval for VYVGART® SC, a subcutaneous form of the drug for treating generalized myasthenia gravis in adult patients. This approval allows for patient self-administration, following the U.S. approval in June. VYVGART® SC is a combination of efgartigimod alfa and Halozyme's ENHANZE® drug delivery technology, approved based on positive results from the Phase 3 ADAPT-SC study.

VYVGART® SC Now Approved for Subcutaneous Administration, Adding to the Already Approved IV Administration

SAN DIEGO, Nov. 16, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that argenx received European Commission (EC) approval of VYVGART® SC (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with ENHANZE® for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. The European approval of VYVGART SC provides the option for patient self-administration. The EC approval is applicable to all 27 European Union Member States plus Iceland, Norway and Liechtenstein.

"We are excited that the European approval of VYVGART SC for patients with generalized myasthenia gravis follows closely on the U.S. approval in June of this year, resulting in many new gMG patients having the option to receive their treatment as a 30-90 second subcutaneous administration," said Dr. Helen Torley, president and chief executive officer of Halozyme.

VYVGART® SC is a subcutaneous product combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART®, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology to facilitate subcutaneous delivery of biologics. VYVGART® SC was approved by the U.S. Food and Drug Administration in June 2023 and is marketed as VYVGART® Hytrulo.

The EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and is based on positive results from the Phase 3 ADAPT-SC study. ADAPT-SC established the efficacy of VYVGART® SC by demonstrating a reduction in anti-AChR antibody levels comparable to VYVGART® IV in adult gMG patients.

About Halozyme

Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 700,000 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, AbbVie, Eli Lilly, Bristol Myers Squibb, Alexion, argenx, Horizon Therapeutics, 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 technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including XYOSTED® and TLANDO® and 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 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 and broadening the treatment options for the indication referred to in this press release. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partners, potential additional data readouts, indications and eligible patients for the ENHANZE® co-formulated treatment referred to in this press release. 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 "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 new ENHANZE® collaborative products are ultimately developed, approved or commercialized or whether additional indications for the ENHANZE® co-formulated treatment referred to in this press release will be approved  for additional indications, unexpected results or delays in development and regulatory review, unexpected regulatory approval requirements, unexpected adverse events or patient 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
609-359-3016
tbui@halozyme.com

Dawn Schottlandt 
Argot Partners
212-600-1902
Halozyme@argotpartners.com

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/halozyme-announces-argenx-receives-european-commission-approval-of-vyvgart-sc-with-enhanze-for-generalized-myasthenia-gravis-301990773.html

SOURCE Halozyme Therapeutics, Inc.

FAQ

What is VYVGART® SC?

VYVGART® SC is a subcutaneous product combination of efgartigimod alfa and recombinant human hyaluronidase PH20, Halozyme's ENHANZE® drug delivery technology to facilitate subcutaneous delivery of biologics.

What is the significance of the European Commission approval for VYVGART® SC?

The approval allows for patient self-administration and expands the treatment options for adult patients with generalized myasthenia gravis.

What study led to the approval of VYVGART® SC?

The EC approval is based on positive results from the Phase 3 ADAPT-SC study, which demonstrated the efficacy of VYVGART® SC by showing a reduction in anti-AChR antibody levels comparable to VYVGART® IV in adult gMG patients.