Docking Devices for Faster and Easier HyQvia Treatment Administration Cleared by FDA

The Food and Drug Administration (FDA) granted 510(k) clearance to the HyHub and HyHub Duo (Takeda, Cambridge, MA) devices, designed to simplify the preparation and administration of HyQvia (Immune Globulin Infusion 10% [Human] with Recombinant Human Hyaluronidase; Takeda, Cambridge, MA). The devices are cleared for use by individuals aged 17 years and older in both the home and clinical setting. In 2014, HyQvia was initially approved for the treatment of people with primary immunodeficiency, followed by an approval for the treatment of people with chronic inflammatory demyelinating polyneuropathy (CIDP) in 2024.

HyHub and HyHub Duo serve as docking stations that allow the components of HyQvia’s dual vial units—immunoglobulin and hyaluronidase—to be combined without the use of needles. According to a statement from Takeda, the devices are intended to reduce the number of supplies and overall complexity of therapy administration by streamlining the transfer and preparation steps. HyHub is optimized for infusions requiring multiple vial units, while HyHub Duo is designed for smaller-volume infusions. Both devices are single-use and disposable, and patients should receive training and instructions from a health care provider before using the devices at home.

The devices are expected to be available in the United States in the second half of 2025 at no additional cost to patients.

Source: Takeda. Takeda receives FDA 51(k) clearance for HyHub and HyHub Duo devices to simplify HYQVIA administration. Businesswire.com. Published 21 July, 2025. Accessed 22 September, 2025. https://www.businesswire.com/news/home/20250721306232/en/Takeda-Receives-FDA-510k-Clearance-for-HyHubTM-and-HyHubTM-Duo-Devices-to-Simplify-HYQVIA-Administration.