SAN
DIEGO, Dec. 30, 2024 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that
argenx's VYVDURA (efgartigimod alfa and hyaluronidase-qvfc), which
is co-formulated with Halozyme's ENHANZE® drug delivery
technology, was granted regulatory approval by Japan's Ministry of Health, Labour and Welfare
(MHLW) for adults with chronic inflammatory demyelinating
polyneuropathy (CIDP). VYVDURA was approved for CIDP as a once
weekly 30-to-90 second subcutaneous injection, which can be
self-administered at home, and is the first and only neonatal Fc
receptor (FcRn) blocker approved for the treatment of CIDP.
"We are pleased that VYVDURA, with our innovative
ENHANZE drug delivery technology, is now approved for two
indications in Japan, enabling
greater flexibility and optionality for generalized myasthenia
gravis and CIDP patients," said Dr. Helen
Torley, president and chief executive officer of Halozyme.
"We look forward to VYVDURA being a new treatment option for an
even broader number of patients in Japan."
The MHLW 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 VYVDURA, 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. Ninety-nine percent of trial participants elected
to participate in the ADHERE+ open-label extension. The safety
results were generally consistent with the known safety profile of
VYVDURA in previous clinical studies and real-world use.
VYVDURA was also approved by the MHLW for
manufacturing and marketing in January
2024 and launched in April
2024 for the treatment of generalized myasthenia gravis
(gMG). In March 2024, VYVDURA was
designated as an Orphan Drug for the treatment of CIDP by the
MHLW.
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 more than 800,000 patient lives in post-marketing use in
nine 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 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, including offering flexibility to receive treatment in
more convenient locations and broadening the treatment options for
the indications 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
"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 unexpected results or delays in 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
609-359-3016
tbui@halozyme.com
Samantha
Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com
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SOURCE Halozyme Therapeutics, Inc.
