Takeda has secured the US Food and Drug Administration (FDA) clearance for its HyHub and HyHub Duo devices, designed to simplify the administration of Hyqvia.
Hyqvia, a combination of IG and hyaluronidase, is intended for the treatment of primary immunodeficiency (PI) and chronic inflammatory demyelinating polyneuropathy (CIDP).
It is approved in the US for adults and children aged two and above with PI, and as maintenance therapy for adults with CIDP.
The administration of Hyqvia involves dual vial units (DVUs) containing immunoglobulin (IG) and hyaluronidase.
HyHub and HyHub Duo serve as docking stations for these vials, reducing the steps needed for infusion preparation, enhancing the convenience and efficiency of administering Hyqvia.
The devices enable patients aged 17 years and older to transfer Hyqvia from vials without needles, facilitating at-home or clinical use.
Additionally, the devices significantly reduce preparation steps and the need for additional supplies.
The development marks a significant advancement in patient care for those requiring immune globulin therapy.
Takeda plasma-derived therapies business unit research and development head and senior vice president Kristina Allikmets said: “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.
“We designed HyHub and HyHub Duo, Takeda’s first customised 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.”
Immune Deficiency Foundation president and CEO Jorey Berry said: “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.”
Hyqvia, containing Recombinant Human Hyaluronidase and immunoglobulins, is approved by the European Medicines Agency (EMA) for PI and secondary immunodeficiency (SID) in adults and children.
It is also approved for CIDP maintenance therapy following stabilisation with intravenous immunoglobulin therapy.
HyHub and HyHub Duo are exclusively for use with Hyqvia and will be provided at no extra cost to patients. Takeda plans to introduce the devices in the US later this year.
The Japanese drugmaker has also submitted a CE mark application in the European Union (EU), with potential expansion to other markets under consideration.
