FDA clears Takeda Devices to simplify at-home immune therapy administration of HYQVIA

Takeda device simplifies at-home administration of HYQVIA: ©Mammadov -stock.adobe.com

The U.S. Food and Drug Administration has granted 510(k) clearance to Takeda’s HyHub and HyHub Duo, two new devices designed to simplify at-home or clinical administration of HYQVIA, the company announced.

The devices enable patients aged 17 and older to transfer HYQVIA’s dual-vial components—immune globulin and recombinant human hyaluronidase—without using a needle. Takeda developed HyHub and HyHub Duo to streamline the infusion process, reducing the number of steps required and minimizing the need for ancillary supplies.

HYQVIA is approved for use in adults and children as young as two years old with primary immunodeficiency (PI), and in adults as maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). The drug can be administered as infrequently as once a month.

“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… with input from patients and caregivers, demonstrating our focus on leveraging technology and deep insights to offer a patient-centric ecosystem of support.”

Compared to traditional pooling bag methods, HyHub can reduce preparation steps by up to 50% when using four dual-vial units (DVUs), while HyHub Duo cuts steps by approximately one-third for two DVUs. Both devices also come with a dedicated carrier bag to aid mobility during the infusion process.

“For people living with primary immunodeficiency, innovative devices that can help simplify the administration process… can be especially meaningful as many require lifelong treatment,” said Jorey Berry, president and CEO of the Immune Deficiency Foundation.

Takeda said the devices will be available at no additional cost to patients starting in the second half of fiscal year 2025. A CE Mark application is also under review in the European Union.

Advancing home-based immunoglobulin therapy

The clearance of HyHub and HyHub Duo highlights a broader trend toward patient-friendly innovations in the treatment of immune disorders. Immunoglobulin therapies, essential for patients with conditions like primary immunodeficiency or autoimmune neuropathies, have traditionally required complex, time-consuming infusion processes that were often confined to clinics or infusion centers.

Recent years have seen growing demand for home-based therapies, driven by advances in device design, digital monitoring tools, and patient-centered care models. New infusion systems increasingly focus on reducing preparation time, enhancing safety, and offering more intuitive interfaces. Innovations in recombinant enzymes and formulation stability have also allowed for less frequent dosing and more comfortable delivery methods.

For patients requiring long-term or lifelong immune globulin therapy, these advancements can significantly improve quality of life. Simplified devices lower the technical burden on patients and caregivers, which may improve adherence and reduce treatment fatigue. The integration of smart technology, such as infusion tracking apps and automated dose logging, is also helping health care providers monitor treatment remotely and intervene when issues arise.

As the health care industry continues to prioritize decentralized care, innovations like HyHub and other simplified delivery systems are expected to play a key role in expanding access to complex biologic therapies—without sacrificing efficacy or safety.