SAN
DIEGO, Jan. 16, 2024 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that
Takeda received U.S. Food and Drug Administration (FDA) approval
for HYQVIA® [Immune Globulin Infusion 10% (Human)]
co-formulated with Halozyme's ENHANZE® drug delivery technology for
the treatment of chronic inflammatory demyelinating polyneuropathy
(CIDP) as maintenance therapy to prevent the relapse of
neuromuscular disability and impairment in adults. HYQVIA® was
first granted FDA approval in 2014 for the treatment of primary
immunodeficiency (PI) in adults, which has since been expanded to
include children 2-16 years old.1
HYQVIA® is the only FDA-approved combination of immunoglobulin
(IG) and hyaluronidase, which makes it a facilitated subcutaneous
immunoglobulin (SCIG) infusion. For adults with CIDP, HYQVIA® can
be infused up to once monthly (every two, three or four weeks) due
to ENHANZE®, which facilitates the dispersion and absorption of
large IG volumes in the subcutaneous space. Because it is delivered
subcutaneously, HYQVIA® can be administered by a healthcare
professional in a medical office, infusion center or at a patient's
home. In addition, it can be self-administered after appropriate
patient or caregiver training.1
"We are pleased that Takeda continues to expand the indications
for HYQVIA®, providing a new personalized maintenance treatment
option for adult patients with CIDP," said Dr. Helen Torley, president and chief executive
officer of Halozyme.
For Full U.S. Prescribing Information, please
visit:
https://www.shirecontent.com/PI/PDFs/HYQVIA_USA_ENG.pdf
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 administration of HYQVIA® .
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 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
References
1 HYQVIA® [Immune Globulin Infusion 10% (Human) with
Recombinant Human Hyaluronidase] U.S. Prescribing Information.
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SOURCE Halozyme Therapeutics, Inc.