Takeda’s New Devices for Hyqvia Infusion Can Reduce Preparation Steps By Up to One-Half

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Takeda’s HyHub and HyHub Duo 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 immune globulin (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 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.

“This milestone exemplifies our dedication to advancing innovative solutions that can enhance the treatment administration experience for people who rely on infusions of facilitated immune globulin like HYQVIA,” said Kristina Allikmets, MD, PhD, senior vice president and head of research and development for the Plasma-Derived Therapies Business Unit at Takeda. “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.”

The duo devices are only intended for use with HYQVIA and will be available at no additional cost to patients. The company expects the devices to available in the United States starting in the second half of fiscal year 2025.