Takeda Receives FDA 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 Needle In Home Environment Or Clinical Setting

• HyHub and HyHub Duo Reduce the Number of Steps Required to Prepare HYQVIA1
• First Devices Customized for a Plasma-Derived Therapy in Takeda's Broad and Differentiated Portfolio Reflect Company's Commitment to Providing a Patient-Centric Ecosystem of Support
• Created With Input from Patients and Caregivers to Help Improve In-Home Infusion

Takeda((TAK) today 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).

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.