- HYQVIA [Immune Globulin Infusion 10% (Human) with
Recombinant Human Hyaluronidase] is the First and Only Facilitated
Subcutaneous Immunoglobulin (fSCIG) Approved in Japan for
Agammaglobulinemia and Hypogammaglobulinemia
- Administration of Recombinant Human Hyaluronidase Prior
to Immunoglobulin Facilitates Subcutaneous Infusion of
Larger Volumes, Potentially Reducing Frequency and Giving Patients
More Flexibility
- Approval Expands Takeda’s Portfolio of Differentiated
Immunoglobulin Therapies and Reflects the Company’s Commitment to
Bring High-Quality Plasma-Derived Therapies to Patients in
Japan
Takeda (TSE:4502/NYSE:TAK) today announced that the Japanese
Ministry of Health, Labour and Welfare has approved the use of
HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant
Human Hyaluronidase] in patients with agammaglobulinemia or
hypogammaglobulinemia1, 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)2. The approval marks availability
of the first and only facilitated subcutaneous immunoglobulin
(fSCIG) therapy as a treatment option for appropriate patients in
Japan.
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). The administration of rHuPH20 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.
The 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.
“We are delighted that HYQVIA, approved in more than 40
countries worldwide, has now been approved in Japan,” said Naoyoshi
Hirota, Regional Head of Research & Development for Takeda’s
Plasma-Derived Therapies Business Unit in Japan. “The subcutaneous
IG therapies currently available in Japan for patients with
agammaglobulinemia or hypogammaglobulinemia require infusion once
every week or every 2 weeks. We are proud to offer Japanese
patients the first and only facilitated subcutaneous treatment
option that offers a reduced dosing frequency of every 3 or 4
weeks.”
“There is a high unmet need for plasma-derived therapies (PDTs)
in patients in Japan, which is anticipated to increase as education
and timely diagnosis rates continue to improve,” said Kristina
Allikmets, head of research & development for Takeda’s
Plasma-Derived Therapies Business Unit. “The approval of HYQVIA,
the first and only facilitated SCIG treatment, is further evidence
of Takeda’s commitment to add to the standard of care for patients
in Japan. We look forward to continuing to bring new therapeutic
options that support and enhance the experience of patients in our
home country throughout the next decade.”
With this approval, Takeda is now able to offer a range of SCIG
therapies to patients based on their individual administrative
needs, reflecting the company’s commitment to offer patients in
Japan a broader choice of treatment options. It also follows the
announcement of a significant investment to build a new
manufacturing facility for plasma-derived therapies (PDTs) in
Osaka, Japan. HYQVIA is also currently under review in Japan for
additional indications.
About Agammaglobulinemia or Hypogammaglobulinemia
Agammaglobulinemia is an inherited disorder caused by a gene
defect that blocks the growth of normal, mature immune cells called
B lymphocytes3. Hypogammaglobulinemia is a condition in which
patients have low levels of antibodies due either to inherited
genetic conditions (PID) or secondary effects (SID) – like
chemotherapy, certain comorbid disorders, or immunosuppressants2.
Individuals with any form of antibody deficiency frequently
experience recurring and/or severe infections, and immunoglobulin
replacement therapy can increase the level of antibodies in the
body.
About Primary Immunodeficiency and Secondary
Immunodeficiency
Primary immunodeficiency describes a heterogeneous group of more
than 480 rare genetic diseases wherein part of the immune system is
missing or not functioning properly4. Secondary immunodeficiency is
defined as an acquired impairment of the immune response resulting
from an underlying condition or factors extrinsic to the immune
system. SID may occur as a consequence of malnutrition, metabolic
disorders, use of immunosuppressive medications, chronic
infections, malignancies, or severe trauma5. Due to their impaired
immune system, patients with PID and SID may be more susceptible to
infection, and it may take longer to recover from it. In patients
with antibody deficiency and increased susceptibility and/or
persistent infections, substitution with functional antibodies
(immunoglobulin replacement therapy) is the standard of care to
support the immune system's functioning5.
About HYQVIA®
HYQVIA is the combination product for subcutaneous injection
containing one each vial of Subcutaneous Immunoglobulin 10%
(SCIG10%) and Recombinant Human Hyaluronidase PH20 (rHuPH20). As of
May 2024, HYQVIA has been approved in more than 40 countries
worldwide.
HYQVIA Product Overview in Japan
Brand Name
HYQVIA 10% Subcutaneous Injection Set
5g/50mL 10g/100mL 20g/200mL
Generic Name
pH4 Treated Acid Human Globulin
(Subcutaneous Injection)
Vorhyaluronidase Alfa (Genetical
Recombination)
Indications
Agammaglobulinemia or
Hypogammaglobulinemia
Dosage and Administration
Human immunoglobulin G is administered
subcutaneously at the same site within approximately 10 minutes
after the subcutaneous injection of vorhyaluronidase alfa
(genetical recombination).
Initiate the treatment with human
immunoglobulin G and vorhyaluronidase alfa (genetical
recombination) at 1/3 or 1/4 of the doses described below, and then
the doses are titrated up. Note that the dosing interval should be
extended depending on the doses.
•Usually, 150 – 600 mg (1.5 – 6 mL)/kg of
body weight of human immunoglobulin G is administered once every 3
weeks or 200 – 800 mg (2 – 8 mL)/kg of body weight of human
immunoglobulin G is administered once every 4 weeks.
•Vorhyaluronidase alfa (genetical
recombination) is administered at the dose of 80 units (0.5 mL) per
1 g of human immunoglobulin G.
The dose and the number of doses per 3 or
4 weeks may be adjusted according to the patient’s condition.
About Takeda
Takeda is focused on creating better health for people and a
brighter future for the world. We aim to discover and deliver
life-transforming treatments in our core therapeutic and business
areas, including gastrointestinal and inflammation, rare diseases,
plasma-derived therapies, oncology, neuroscience and vaccines.
Together with our partners, we aim to improve the patient
experience and advance a new frontier of treatment options through
our dynamic and diverse pipeline. As a leading values-based,
R&D-driven biopharmaceutical company headquartered in Japan, we
are guided by our commitment to patients, our people and the
planet. Our employees in approximately 80 countries and regions are
driven by our purpose and are grounded in the values that have
defined us for more than two centuries. For more information, visit
www.takeda.com.
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______________________________ REFERENCES 1 HYQVIA 10%
Subcutaneous Injection Set Package Insert in Japan. 2 Pimenta et
al. Hypogammaglobulinemia: a diagnosis that must not be overlooked.
BJMBR. 2019;52(10): e8926. 3 National Organization for Rare
Disorders
https://rarediseases.org/rare-diseases/agammaglobulinemia/ 4 Tangye
et al. Human Inborn Errors of Immunity: 2022 Update on the
Classification from the International Union of Immunological
Societies Expert Committee. J Clin Immunol. 2022;42(7):1473-1507. 5
Tuano KS, Seth N, Chinen J. Secondary immunodeficiencies: An
overview. Ann Allergy Asthma Immunol. 2021;127(6):617-626.
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version on businesswire.com: https://www.businesswire.com/news/home/20241219442534/en/
Media:
International Media Kristine Kelly
Kristine.Kelly@takeda.com +41 79 268 68 21
Japanese Media Shigeyuki Matsui
Shigeyuki.Matsui@takeda.com +81 (80) 3594-2460
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