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. 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. 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.
“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.
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).
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