VYVDURA® provides patients with option for
self-administration
SAN
DIEGO, Jan. 18, 2024 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that
argenx received approval from Japan's Ministry of Health, Labour and Welfare
(MHLW) for VYVDURA® (efgartigimod alfa and
hyaluronidase-qvfc) injection co-formulated with Halozyme's
ENHANZE® drug delivery technology for subcutaneous (SC)
use for the treatment of adult patients with generalized myasthenia
gravis (gMG), who do not have sufficient response to steroids or
non-steroidal immunosuppressive therapies.
"We are pleased that argenx continues to expand its global reach
of ENHANZE-enabled subcutaneous VYVGART to Japan," said Dr. Helen
Torley, president and chief executive officer of Halozyme.
"Today's approval includes the opportunity for patient
self-administration of SC VYVGART with ENHANZE at home, adding an
additional treatment option for patients."
The approval of VYVDURA® is based on positive results
from the Phase 3 ADAPT-SC study. ADAPT-SC established the efficacy
of VYVDURA® by demonstrating a reduction in
percent change from baseline in total immunoglobulin G (IgG) levels
comparable to VYVGART® IV in adult gMG patients.
ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which
formed the basis for approval of VYVGART® in
Japan in January 2022.
VYVDURA® is the brand name in Japan for what is branded as
VYVGART® Hytrulo in the United
States.
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 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, 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 Hylenex® and XYOSTED® 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
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 and
alleviating pressure on health care system resources, including
potential out-of-hospital self-administration of
VYVDURA® . 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, potential regulatory
approvals, indications and product launches). These 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 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 Reports on Form 10-Q filed with
the Securities and Exchange Commission.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Samantha Gaspar
Teneo
617-877-9710
samantha.gaspar@teneo.com
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SOURCE Halozyme Therapeutics, Inc.