Halozyme Announces argenx Receives FDA Approval for VYVGART® Hytrulo With ENHANZE® for Subcutaneous Use in Generalized Myasthenia Gravis

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Jun 20, 2023, 18:30 ET

VYVGART® Hytrulo is first FDA-approved subcutaneous (SC) injectable for generalized myasthenia gravis (gMG)

SAN DIEGO, June 20, 2023 /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) injection with ENHANZE® for subcutaneous (SC) use for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

VYVGART® Hytrulo 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. The product is to be administered subcutaneously by a healthcare professional as a single injection (1,008 mg fixed dose) over 30-90 seconds in cycles of once weekly injections for four weeks.

"We are pleased that argenx has received FDA approval for the subcutaneous form of efgartigimod, which reinforces their commitment to the patient community with a broadening of treatment options that brings flexibility for patients," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We look forward to the multiple data readouts this year for subcutaneously administered efgartigimod in additional autoimmune conditions, with the potential to expand the number of approved indications and eligible patients."

This FDA approval is based on positive results from the Phase 3 ADAPT-SC study, which established the efficacy of VYVGART® Hytrulo by demonstrating a reduction in anti-AChR antibody levels comparable to intravenous VYVGART® in adult gMG patients. ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of intravenous VYVGART® in December 2021.

Reference Prescribing Information for VYVGART® Hytrulo.

About Halozyme Therapeutics, Inc.

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 five 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 and Chugai Pharmaceutical.

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^®, TLANDO^® and NOCDURNA^® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceutical, Pfizer 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
[email protected]

Dawn Schottlandt
Argot Partners
212-600-1902
[email protected]

SOURCE Halozyme Therapeutics, Inc.