FDA Approves IgG-Hyaluronidase Recombinant for the Treatment of Adult Patients With CIDP

The FDA announced its approval of immune globulin infusion 10% with recombinant human hyaluronidase (IgG-hyaluronidase recombinant, Hyqvia; Baxalta US) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adult patients. The approval comes after results of the ADVANCE-CIDP 1 study and its extension trial ADVANCE-CIDP 3, which evaluated the safety and efficacy of IgG-hyaluronidase recombinant as a maintenance therapy in adults with CIDP.

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Previously, IgG-hyaluronidase recombinant was approved by the FDA for the treatment of primary immunodeficiency in adult patients, and since its approval in 2014, it has been expanded to include pediatric patients aged 2 to 16 years. IgG-hyaluronidase recombinant is the only combination of immunoglobulin and hyaluronidase to be approved by the FDA, making it a facilitated subcutaneous immunoglobulin infusion. For adult patients with CIDP, IgG-hyaluronidase recombinant can be infused up to once monthly—every 2, 3, or 4 weeks—because of the hyaluronidase component of the treatment regimen. In addition, because it is given subcutaneously, IgG-hyaluronidase recombinant can be administered in a medical office, infusion center, or at a patient’s home.

“With the FDA approval of [IgG-hyaluronidase recombinant] for CIDP, which builds on our expertise in rare neuroimmunological and neuromuscular disorders, we can now offer a personalized maintenance treatment option for adults with this debilitating disease,” said Giles Platford, president of Plasma-Derived Therapies Business Unit, Takeda, in a press release. “Research and clinical experience have shown that IG therapy is effective as maintenance treatment in adults with CIDP, and we hope that this approval for [IgG-hyaluronidase recombinant] is the first of several around the world as we strive to deliver our broad and diverse IG portfolio to more people with complex neuroimmunological diseases.”

The randomized, double-blind, placebo-controlled study ADVANCE-CIDP 1 evaluated the efficacy and safety of IgG-hyaluronidase recombinant as a maintenance therapy in 122 adult patients with CIDP who remained on a stable dosing regimen of intravenous immunoglobulin therapy (IVIG) for at least 3 months prior to screening. The analysis demonstrated a statistically significant difference between the relapse rates of those in the IgG-hyaluronidase recombinant group (14.0%; n = 57) compared to those in the placebo group (32.3%; n = 65).

Further, the safety of IgG-hyaluronidase recombinant in adult patients with CIDP was evaluated across the 2 trials. The most common reported adverse events (reported in >5% of patients in the trials) were local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritus, increased lipase, abdominal pain, back pain, and pain in extremity.

“While it is considered the standard-of-care for maintenance treatment of adults with CIDP, IVIG infusions may be challenging for some patients and their caregivers,” said Lisa Butler, executive director, GBS-CIDP Foundation International, in the press release. “We’re excited that this therapy could offer some adults with CIDP an alternative subcutaneous option that may address some of these challenges and help personalize treatment.”

Reference

Takeda. U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). News release. January 16, 2024. January 16, 2024. 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