Takeda Gains FDA 510(k) Clearance for HyHub™ and HyHub™ Duo to Enhance HYQVIA® Administration Experience for Patients with Primary Immunodeficiency and CIDP
Takeda (TSE:4502/NYSE:TAK), a global biopharmaceutical leader, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its newly developed medical devices—HyHub™ and HyHub™ Duo. These two proprietary infusion devices are designed specifically for use with HYQVIA® [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase]. The clearance covers usage in patients aged 17 and older, enabling a streamlined, needle-free transfer of HYQVIA from vials during infusion, whether at home or in a clinical setting.
This development marks a notable step forward in Takeda’s efforts to modernize and simplify the administration process of HYQVIA, a dual-vial unit (DVU) treatment consisting of one vial of immunoglobulin (IG) and one vial of hyaluronidase. The HyHub and HyHub Duo act as specialized docking stations for the DVUs, aiming to minimize complexity and reduce the number of steps involved in the preparation and administration of HYQVIA infusions.
A Strategic Innovation for Chronic Conditions
HYQVIA is approved in the United States for use in adults and children aged two years and older with primary immunodeficiency (PI), as well as for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy. Both PI and CIDP are chronic conditions that often require lifelong management with regular immunoglobulin therapy. HYQVIA offers the advantage of facilitated subcutaneous immunoglobulin (SCIg) administration, and depending on the patient’s condition and physician’s guidance, the infusion frequency can be as low as once every four weeks.
For many patients and caregivers, the infusion process can be a time-consuming and resource-intensive task. By streamlining this process, HyHub and HyHub Duo have the potential to significantly improve the overall treatment experience, particularly for those managing their therapy at home.
Elevating the Patient Experience
Kristina Allikmets, Senior Vice President and Head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit, emphasized the company’s commitment to patient-focused innovation:
“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 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 HyHub devices represent a tangible example of how Takeda is integrating patient and caregiver feedback into its product development strategy. These devices were crafted not only with functionality in mind but also with convenience and usability at the forefront.
Reduced Complexity, Enhanced Mobility
One of the key advantages of HyHub and HyHub Duo is their ability to significantly reduce the complexity of preparing a HYQVIA infusion. According to Takeda, the devices can cut the number of steps needed for preparation by up to 50%, depending on which device is used and the number of DVUs being prepared. This simplification also reduces the reliance on ancillary supplies, such as pooling bags and needles, making the process safer and less cumbersome.
Furthermore, Takeda has introduced a custom-designed carrier bag for the devices, which allows for easier mobility within the home. This addition is particularly useful for patients who prefer flexibility during the infusion process, allowing them to move from room to room without disrupting the therapy.
Community Reception and Relevance
The patient advocacy community has responded positively to this innovation. Jorey Berry, President and CEO of the Immune Deficiency Foundation, highlighted the importance of simplifying treatment regimens for individuals with PI:
“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.”
Indeed, for many individuals managing PI or CIDP, treatment adherence can be influenced by how complex or time-consuming their infusion protocol is. By removing logistical barriers and offering user-friendly tools, Takeda aims to improve treatment continuity and quality of life for these patients.
No Added Cost to Patients
Importantly, Takeda stated that HyHub and HyHub Duo will be made available at no additional cost to patients. This ensures equitable access to the devices and removes financial barriers to adopting more efficient infusion practices.
The devices are intended exclusively for use with HYQVIA and are not compatible with other therapies or treatments. This ensures that the administration process remains standardized and consistent, thereby minimizing the risk of errors and optimizing efficacy.
Commercial Rollout and Global Outlook
Takeda anticipates that HyHub and HyHub Duo will become available in the United States starting in the second half of fiscal year 2025. The company has also taken proactive steps to expand access to international markets by submitting a CE Mark application for both devices in the European Union during the first quarter of fiscal year 2025. This marks the beginning of Takeda’s broader strategy to introduce the HyHub platform into additional global markets, subject to regulatory approvals.
This global approach reflects Takeda’s long-term vision to evolve the patient experience not just in North America, but around the world. The company’s investment in delivery innovation underscores its belief that medical devices can play a pivotal role in chronic disease management, particularly in complex therapeutic areas like immunology and neurology.
A Broader Context: Plasma-Derived Therapies at the Core
The introduction of HyHub and HyHub Duo also illustrates Takeda’s ongoing commitment to its Plasma-Derived Therapies (PDT) Business Unit. Over the past few years, Takeda has prioritized growth and modernization in this segment, including enhancements in manufacturing, digital health integration, and therapy delivery. The new devices represent the first customized administration tools developed specifically for a Takeda plasma-derived therapy, signaling a new era of user-centric innovation in this field.
These efforts align with Takeda’s broader mission to deliver transformative therapies that are not only clinically effective but also accessible, sustainable, and easy to integrate into patients’ daily lives. The company continues to invest in developing tools and technologies that extend beyond the medicine itself—addressing the practical, emotional, and logistical challenges faced by patients and caregivers throughout the treatment journey.
Takeda’s FDA 510(k) clearance for HyHub™ and HyHub™ Duo marks a meaningful advancement in the administration of HYQVIA for patients with primary immunodeficiency and chronic inflammatory demyelinating polyneuropathy. By reducing preparation complexity, enhancing home-based care, and incorporating patient-driven design elements, these devices reflect a deepened commitment to innovation with empathy.
As these new devices head toward commercial availability in the United States and potentially the European Union, Takeda stands poised to redefine how plasma-derived therapies are delivered, empowering patients with more efficient, comfortable, and personalized treatment experiences.
