Takeda Gets FDA 510(k) Clearance For HyHub™ And HyHub™ Duo Devices To Make HYQVIA® Administration Easier

Takeda has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for two new devices, HyHub and HyHub Duo designed to support the administration of HYQVIA in patients aged 17 and older. These devices allow HYQVIA, a treatment that combines immune globulin (IG) and recombinant human hyaluronidase, to be transferred from vials without the use of a needle, offering patients and healthcare providers a simpler and more convenient method for administering the therapy at home or in clinical settings.

HYQVIA is approved in the United States for the treatment of adults and children as young as two years with primary immunodeficiency (PI) and for maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The therapy is delivered subcutaneously and can be infused once every two, three, or four weeks, depending on the condition being treated. Each dose includes dual vial units (DVUs) that contain one vial of immunoglobulin and one vial of hyaluronidase.

Kristina Allikmets, senior vice president and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit, said in a statement, “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. 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.”

Jorey Berry, president and chief executive officer of the Immune Deficiency Foundation, stated, “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.”

The newly cleared devices, HyHub and HyHub Duo, serve as docking stations for these dual vial units and are specifically designed to streamline the preparation process for HYQVIA infusions. Compared to using a pooling bag, these devices can cut the number of preparation steps by up to half, depending on how many DVUs are being used and which device is selected. In addition to simplifying the process, they reduce the need for ancillary supplies and come with a specially designed carrier bag that makes it easier to move the system between rooms.

Both HyHub and HyHub Duo are intended solely for use with HYQVIA and will be offered to patients at no additional cost. Takeda plans to make the devices available in the U.S. starting in the second half of its fiscal year 2025. A CE Mark application has also been submitted in the European Union during the first quarter of fiscal year 2025, and Takeda is considering the potential for launching the devices in other international markets in the future.