Takeda receives FDA clearance for HyHub, HyHub Duo

Takeda (TAK) announced that the FDA has granted 510(k) clearance for HyHub and HyHub Duo, devices for patients 17 years of age and older that allow Hyqvia 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 including one vial of immunoglobulin 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. Takeda anticipates making HyHub and HyHub Duo available in the United States starting in the second half of FY25. 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.