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Takeda Receives FDA 510(k) Clearance for HyHubTM and HyHubTM Duo Devices to Simplify HYQVIA® Administration

Business Wire India Monday, 21 July 2025
*Business Wire India* 

· *HyHub and HyHub Duo Reduce the Number of Steps Required to Prepare HYQVIA1*
· *First Devices Customized for a Plasma-Derived Therapy in Takeda’s Broad and Differentiated Portfolio Reflect Company’s Commitment to Providing a Patient-Centric Ecosystem of Support*
· *Created With Input from Patients and Caregivers to Help Improve In-Home Infusion*
Takeda *(**TSE:4502/NYSE:TAK**) *today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for HyHub^TM and HyHub^TM Duo, devices for patients 17 years of age and older that allow HYQVIA^® [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] to be transferred from vials without using a needle in a home environment or clinical setting.^2 The HYQVIA administration process consists of dual vial units (DVUs) including one vial of immunoglobulin (IG) and one vial of hyaluronidase. HyHub and HyHub Duo, which act as docking stations for these vials, were developed to simplify administration of HYQVIA by reducing the number of steps required to prepare the infusion of two DVUs or more.^1   HYQVIA is a combination of IG and hyaluronidase for facilitated subcutaneous immunoglobulin (SCIg) infusion that is approved for treatment of adults and children two years of age and older with primary immunodeficiency (PI) and as maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) in the United States.^2 Depending on the indication, HYQVIA can be infused up to once monthly (every two, three or four weeks).     “This milestone exemplifies our dedication to advancing innovative solutions that can enhance the treatment administration experience for people who rely on infusions of facilitated immunoglobulin like HYQVIA,” said Kristina Allikmets, senior vice president and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit. “We designed HyHub and HyHub Duo, Takeda’s first customized devices for use with a plasma-derived therapy, with input from patients and caregivers, demonstrating our focus on leveraging technology and deep insights to offer a patient-centric ecosystem of support throughout the treatment journey.”     HyHub and HyHub Duo reduce the number of steps required to prepare the IG and hyaluronidase of the HYQVIA infusion by up to half compared to infusing with a pooling bag depending on the device and number of DVUs used.^1* HyHub and HyHub Duo also reduce the ancillary supplies required to prepare the infusion and a dedicated carrier bag is available for convenience that enables room-to-room mobility.^3     “For people living with primary immunodeficiency, innovative devices that can help simplify the administration process of their immunoglobulin treatment can be especially meaningful as many require lifelong treatment for their disease,” said Jorey Berry, president and chief executive officer of the Immune Deficiency Foundation.     HyHub and HyHub Duo are intended for use only with HYQVIA and the devices will be available at no additional cost to patients.     Takeda anticipates making HyHub and HyHub Duo available in the United States starting in the second half of fiscal year 2025. Takeda also submitted a CE Mark application for HyHub and HyHub Duo in the European Union during the first quarter of fiscal year 2025 and will evaluate making the device available in other markets in the future.     * HyHub reduces the number of steps by approximately half for four DVUs. HyHub Duo reduces the number of steps by about one third for two DVUs.     *About HYQVIA*^*®** [I**mmune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase]*
HYQVIA^® is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins (Ig) and is approved in the United States to treat adults and children two years of age and older with primary immunodeficiency (PI), and as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adult patients with CIDP. It is also approved by the European Medicines Agency (EMA) as a replacement therapy in adults, children and adolescents with PI and with secondary immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF) or serum IgG level of 5% of patients in the clinical trials were:     Primary Immunodeficiency (PI): Local reactions, headache, antibody formation against rHuPH20, fatigue, nausea, pyrexia, and vomiting.     Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritus, increased lipase, abdominal pain, back pain, and pain in extremity.     *Drug Interactions*     Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella).     *Use in Specific Populations*     *Pregnancy:* Limited human data are available on the use of HYQVIA during pregnancy. The effects of antibodies to the Recombinant Human Hyaluronidase on the human embryo or fetal development are unknown. It is not known whether HYQVIA can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. HYQVIA should be given to a pregnant woman only if clearly needed.     *Please click for **Full Prescribing Information.*     *For European Union Summary of Product Characteristics, please visit: *https://www.ema.europa.eu/en/medicines/human/EPAR/hyqvia     *About Takeda*
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com.     *Important Notice*
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.     *Forward-Looking Statements*
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This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.     *References*     ^1 Data on File. Takeda Pharmaceuticals.
^2 HYQVIA [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] U.S. Prescribing Information.
^3 Data on File. Takeda Pharmaceuticals.       View source version on businesswire.com: https://www.businesswire.com/news/home/20250721306232/en/  
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