Takeda has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its new medical devices, HyHub™ and HyHub™ Duo. These innovations are designed to simplify the administration of HYQVIA®, an immunoglobulin therapy used to treat primary immunodeficiency (PI) and chronic inflammatory demyelinating polyneuropathy (CIDP).
The devices are approved for use in patients aged 17 and older, offering a needle-free method for transferring HYQVIA from vials during home or clinical treatment. According to Takeda, HyHub and HyHub Duo function as docking stations for the dual vial units (DVUs) that comprise one vial of immune globulin (IG) and one of recombinant human hyaluronidase.
HYQVIA is a subcutaneous immunoglobulin (SCIg) therapy that can be administered once every two to four weeks, depending on the patient’s diagnosis. The combination therapy is approved in the U.S. for adults and children aged two and older with PI, and for adults with CIDP as a maintenance treatment.
Kristina Allikmets, Senior Vice President and Head of R&D for Takeda’s Plasma-Derived Therapies Business Unit, highlighted the patient-centric design of the devices:
“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.”
Developed with direct input from patients and caregivers, HyHub and HyHub Duo aim to streamline the HYQVIA infusion process. For example, the HyHub device can reduce the number of preparation steps by approximately 50% for four DVUs, while the HyHub Duo can reduce steps by about one-third for two DVUs, compared to traditional pooling bag methods.
Beyond simplifying steps, the devices require fewer ancillary supplies, and Takeda is offering a dedicated carrier bag to aid room-to-room mobility during home treatment.
Jorey Berry, President and CEO of the Immune Deficiency Foundation, emphasized the impact of this development:
“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.”
Importantly, Takeda confirmed that the HyHub and HyHub Duo will be provided at no additional cost to patients. Availability in the U.S. is expected in the second half of fiscal year 2025.
Additionally, Takeda has submitted a CE Mark application in the European Union and is exploring opportunities to expand access to other global markets.
This FDA clearance marks a significant step in the evolution of patient-led homecare for chronic immunodeficiency conditions, combining medical innovation with everyday practicality.
