CAMBRIDGE, Mass. — Takeda has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its HyHub™ and HyHub™ Duo devices, designed to streamline at-home and clinical administration of HYQVIA®, the company’s plasma-derived therapy for primary immunodeficiency (PI) and chronic inflammatory demyelinating polyneuropathy (CIDP).
The new devices are intended for patients aged 17 and older and eliminate the need for needles when transferring HYQVIA from its vials. Acting as docking stations, HyHub and HyHub Duo reduce the number of steps needed to prepare infusions involving two or more dual vial units (DVUs), which include separate vials of immunoglobulin (IG) and hyaluronidase.
“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 and 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.”
HYQVIA is approved in the U.S. for adults and children as young as two for the treatment of PI, and as maintenance therapy for adults with CIDP. Depending on the condition, the treatment can be infused as infrequently as once every four weeks.
According to Takeda, the new devices can cut infusion preparation steps by up to 50 percent compared to traditional methods involving pooling bags, and also reduce the amount of ancillary supplies needed. Both HyHub models will be provided to patients at no additional cost, with a custom carrier bag available for greater mobility during in-home use.
“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 CEO of the Immune Deficiency Foundation.
Takeda plans to launch HyHub and HyHub Duo in the U.S. in the second half of fiscal year 2025. The company has also submitted a CE Mark application for the devices in the European Union and may consider future expansion to additional markets.
