Takeda gets USFDA 510(k) clearance for HyHub, HyHub Duo devices to simplify HYQVIA administration
Osaka: Takeda has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for HyHub and HyHub Duo, devices for patients 17 years of age and older that allow HYQVIA [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] to be transferred from vials without using a needle in a home environment or clinical setting.
The HYQVIA administration process consists of dual vial units (DVUs) including one vial of immunoglobulin (IG) and one vial of hyaluronidase. HyHub and HyHub Duo, which act as docking stations for these vials, were developed to simplify administration of HYQVIA by reducing the number of steps required to prepare the infusion of two DVUs or more.
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.
