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
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SOURCE Halozyme Therapeutics, Inc.