FDA Clears HyHub and HyHub Duo Devices for Easier Administration of Immune Globulin Infusion, Hyqvia

Kristina Allikmets, MD, PhD

(Credit: LinkedIn)

According to a new announcement, the FDA has granted 510(k) clearance to Takeda’s HyHub and HyHub Duo devices for patients aged 17 years and older which allow immune globulin (IG) infusion 10% (human) with recombinant human hyaluronidase (Hyqvia), an approved treatment for chronic inflammatory demyelinating polyneuropathy (CIDP), to be transferred from vials needle-free in home or clinical settings. The company expects the devices to available in the United States starting in the second half of fiscal year 2025.¹

HyHub and HyHub Duo serve as docking stations for the dual vial units (DVUs) used in Hyqvia administration, which consists of 1 vial of immunoglobulin (IG) and 1 vial of hyaluronidase. These devices can reduce the number of preparation steps by up to half compared with using a pooling bag, depending on the device and number of DVUs used. In addition, HyHub and HyHub Duo help minimize the ancillary supplies needed for infusion preparation. Takeda noted that a dedicated carrier bag is also available to support room-to-room mobility.

“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,” Kristina Allikmets, MD, PhD, senior vice president and head of Research & Development for the Plasma-Derived Therapies Business Unit at Takeda, said in a statement.¹ “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 company noted that these duo devices are only intended for use with Hyqvia and will be available at no additional cost to patients. In addition, Takeda also submitted a CE Mark application for the devices in the European Union during the first quarter of fiscal year 2025 and will assess making them available in other markets in the future.

READ MORE: FDA Shuts Down Sarepta's Distribution of Gene Therapy Elevidys Following Patient Deaths

“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,” Jorey Berry, president and chief executive officer at the Immune Deficiency Foundation, said in a statement.¹

Hyqvia is a combination of IG and hyaluronidase for facilitated subcutaneous immunoglobulin (SCIg) infusion that was approved by the FDA for treatment of adults and children 2 years of age and older with primary immunodeficiency (PI) in 2014 and as maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) in January 2024. The approval for CIDP was based on findings from the randomized, double-blinded, placebo-controlled ADVANCE-CIDP 1 trial (NCT02549170) and the single-arm, open-label, extension ADVANCE-CIDP 3 study (NCT02955355) that assessed the efficacy and safety of Hyqvia in adults with CIDP.²

In the trial, the primary end point among 122 patients showed a statistical difference between the relapse rates in the Hyqvia group (n = 57; 14.0%) compared with the placebo group (n = 65; 32.3%), which was significant (P = .0314). The efficacy assessment on Hyqvia included adults with a confirmed diagnosis of CIDP and who had remained on a stable dosing regimen of intravenous immunoglobulin (IVIG) therapy for at least 3 months before screening. The treatment difference of -18.3% (2-sided 95% CI, -32.1% to -3.1%) indicated that Hyqvia displayed superiority over placebo in preventing relapse of CIDP.

The safety of Hyqvia in adults with CIDP was assessed across participants in ADVANCE-CIDP 1 (n = 62) and ADVANCE-CIDP 3 (n = 79). The most common adverse effects observed in at least 5% of study participants in the clinical trials of Hyqvia for CIDP included local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritus, increased lipase, abdominal pain, back pain, and pain in extremity.

REFERENCES
1. Takeda Receives FDA 510(k) Clearance for HyHub and HyHub Duo Devices to Simplify HYQVIA Administration. News Release. Takeda. Published July 21, 2025. Accessed July 21, 2025. https://www.takeda.com/newsroom/newsreleases/2025/hyhub/
2. U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). News Release. Takeda. Published January 16, 2024. Accessed July 21, 2025. https://www.takeda.com/en-us/newsroom/news-releases/2024/us-fda-approves-takedas-hyqvia-as-maintenance-therapy-in-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp