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

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^® [Immune 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 <4 g/L. In addition, it is approved by the EMA as maintenance therapy in adults, children and adolescents (0-18 years) with CIDP after stabilization with intravenous immunoglobulin therapy (IVIG). HYQVIA is infused under the skin into the fatty subcutaneous tissue. HYQVIA contains IG collected from human plasma. IG are antibodies that maintain the body’s immune system. The hyaluronidase part of HYQVIA facilitates the dispersion and absorption of IG in the subcutaneous space between the skin and the muscle. HYQVIA is infused up to once a month (every two, three or four weeks for CIDP; every three or four weeks for PI).

HyHub/HyHub Duo Important Information for Healthcare Providers

Intended Use: HyHub/HyHub Duo are stand-alone, single-use, disposable vial access devices.

Indications for Use: HyHub/HyHub Duo are indicated for patients 17 years of age and older to allow HYQVIA [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] to be transferred from vials without using a needle, as prescribed, in a home environment or clinical setting.

Contraindications:

• Do not use HyHub/HyHub Duo with a pooling bag.
• Do not connect HyHub/HyHub Duo to a syringe driver infusion pump.

Selected Information for Patients:

• HyHub/HyHub Duo are for SINGLE USE ONLY, even if all docks are not used during a single infusion. Re-use will increase risk of infection. Patients should always use a new HyHub/HyHub Duo for each infusion.
• Only use HyHub/HyHub Duo when patients are ready to administer HYQVIA.
• Patients should not use HyHub/HyHub Duo at home until receiving instructions and training from a healthcare provider.
• HYQVIA is the only medication that may be used with HyHub/HyHub Duo.
• Patients should not exceed the maximum infusion volume per infusion site or infusion rate as indicated in the HYQVIA prescribing information.

For safe and proper use of HyHub/HyHub Duo, please refer to the complete Instructions for Use included with the devices when they become available in the second half of FY2025. For information about HYQVIA, please see Prescribing Information for HYQVIA.

INDICATIONS FOR HYQVIA
HYQVIA is indicated for the treatment of primary immunodeficiency (PI) in adults and pediatric patients two years of age and older and for chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults. HYQVIA is for subcutaneous use only.

IMPORTANT SAFETY INFORMATION FOR HYQVIA

WARNING: THROMBOSIS Thrombosis may occur with immune globulin (IG) products, including HYQVIA. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer HYQVIA at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.

Contraindications

• History of anaphylactic or severe systemic hypersensitivity reactions to human IG
• IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to human IG
• Known systemic hypersensitivity to hyaluronidase including Recombinant Human Hyaluronidase of HYQVIA
• Known systemic hypersensitivity to human albumin (in the hyaluronidase solution)

Warnings and Precautions

Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients previously treated with IG products. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis.

Thrombosis: Has been reported to occur following treatment with IG products, including HYQVIA and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Immunogenicity of Recombinant Human Hyaluronidase (rHuPH20): Has been reported to occur following treatment with IG products, including HYQVIA and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Aseptic Meningitis Syndrome: Has been reported to occur with use of IG, including HYQVIA. The syndrome usually begins within several hours to two days following IG treatment.

Conduct a thorough neurological exam on patients exhibiting signs and symptoms, to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae.

Hemolysis: HYQVIA contains blood group antibodies which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing.

Renal Dysfunction/Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, may occur with IG products, including HYQVIA. Ensure patients are not volume depleted prior to infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, administer HYQVIA at the minimum rate of infusion practicable. Assess renal function before initiation and throughout treatment, and consider lower, more frequent dosing. If renal function deteriorates, consider discontinuation.

Spread of Localized Infection: Do not infuse HYQVIA into or around an infected area due to potential risk of spreading a localized infection.

Transfusion-Related Acute Lung Injury: Non-cardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. Manage using oxygen therapy with adequate ventilatory support.

Transmittable Infectious Agents: Because HYQVIA is made from human plasma, there is a risk of transmitting infectious agents (e.g. viruses, other pathogens).

Interference with Lab Tests: False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies.

Adverse Reactions

The most common adverse reactions observed in >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.

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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.

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