SAN
DIEGO, Dec. 30, 2024 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that
Takeda received regulatory approval for HYQVIA® [Immune
Globulin Infusion 10% (Human) with Halozyme's Recombinant Human
Hyaluronidase] by the Japanese Ministry of Health, Labour and
Welfare (MHLW) for patients with agammaglobulinemia or
hypogammaglobulinemia, disorders characterized by very low or
absent levels of antibodies and an increased risk of serious
recurring infection caused by primary immunodeficiency (PID) or
secondary immunodeficiency (SID).
HYQVIA® is the first plasma-derived
therapy for subcutaneous injection in Japan that consists of a combination of one
vial of Immunoglobulin 10% and one vial of Recombinant Human
Hyaluronidase PH20 (rHuPH20), which is Halozyme's
ENHANZE® drug delivery technology. The administration of
ENHANZE® increases the dispersion and absorption of
immunoglobulin (IG) in the subcutaneous tissue, allowing larger
volumes to be infused in the infusion site. This allows for less
frequent dosing compared to other subcutaneous IG products, while
avoiding the need for venous access. The ability to infuse a larger
infusion volume is expected to increase administration flexibility
for patients with agammaglobulinemia or hypogammaglobulinemia by
decreasing the dosing frequency to once every 3 or 4 weeks, as
compared to weekly or bi-weekly with conventional SCIG
treatments.
"We are very pleased that patients in Japan with agammaglobulinemia or
hypogammaglobulinemia can now access HYQVIA, which represents the
first and only subcutaneous immunoglobulin therapy that offers the
potential of a reduced dosing frequency," said Dr. Helen Torley, president and chief executive
officer of Halozyme. "We appreciate the opportunity to continue to
provide patients with more flexible treatment options with our
innovative drug delivery technology."
The MHLW approval is based on data from two
pivotal Phase 3, open-label, non-controlled studies evaluating the
efficacy, safety, tolerability and pharmacokinetics in Japanese
subjects with PID (NCT05150340, NCT05513586). In these studies, the
efficacy and safety profile of HYQVIA® in 16 patients
aged 2 years or older in Japan
were evaluated based on the results of the clinical trials. The Geo
Mean of IgG trough level at the last 3 visits was 9.494g/L and was
maintained at level comparable to treatment with intravenous or
subcutaneous immunoglobulin (Geo Mean of IgG trough level
9.624g/L). The major adverse reactions were pyrexia 5 patients
(31.3%) and infusion site erythema, injection site erythema,
infusion site swelling, infusion site pain, and headache (12.5%)1.
Data from two Phase 3 clinical trials conducted in patients with
PID in North America (NCT00814320,
NCT01175213) was also included in the submission.
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 larger volumes of injectable medications
through subcutaneous delivery and potentially lowering the
treatment burden for patients, including less frequent dosing and
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.