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.