The Future of Chronic Inflammatory Demyelinating Polyneuropathy Treatment With the FDA Approval of Hyqvia: Richard Lewis, MD

WATCH TIME: 5 minutes

"The announcement that Hyqvia has been approved for CIDP is another piece of ammunition in our ability to treat the patients with this disorder. The advantage of Hyqvia is that you can get a fairly large volume of immunoglobulin in without needing an intravenous, eliminating concerns about venous access. I'm excited that we have this option!"

Patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a neurological disorder, typically experience progressive weakness and have a reduction in senses of the arms and legs caused by damage to the fat-based protective covering on nerves. According to the National Institute of Neurological Disorders and Stroke, other symptoms of CIDP include fatigue or feeling tired and unusual feelings in the body.¹ Therapies for patients with CIDP may include prescribing steroid medicine and other immune system focused treatments, along with physical therapy.

In recent news, the FDA approved immune globulin (IG) infusion 10% (human) with recombinant human hyaluronidase (Hyqvia; Takeda Pharmaceuticals), as a maintenance therapy for adults with CIDP.² The approval was based on 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 Hyqvia in adults with CIDP. The analysis of the primary end point among 122 patients with CIDP from ADVANCE-CIDP 1 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 considered significant (P = .0314).³

Following the news of the approval, Richard Lewis, MD, director of the electromyography laboratory and professor of neurology at Cedars-Sinai Medical Center, sat down in an interview with NeurologyLive® to share his reaction. He discussed how the approval marks a significant advancement in the field, especially since it is only FDA-approved combination of IG and hyaluronidase. He also talked about advantages Hyqvia offers over traditional intravenous immunoglobulin treatments for patients with CIDP. Lewis, also a consultant for Takeda, spoke about how the potential shift to a 20% solution might impact the future of CIDP therapy and patient convenience.

REFERENCES
1. National Institute of Neurological Disorders and Stroke. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Accessed January 19, 2024. https://www.ninds.nih.gov/health-information/disorders/chronic-inflammatory-demyelinating-polyneuropathy-cidp
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 January 19, 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
3. Takeda presents full data set from phase 3 ADVANCE-CIDP 1 clinical trial investigating Hyqvia as a maintenance therapy for chronic inflammatory demyelinating polyneuropathy at PNS Annual Meeting. News release. June 20, 2023. Accessed January 19, 2024. https://www.takeda.com/en-us/newsroom/news-releases/2023/takeda-presents-full-data-set-from-phase-3-ADVANCE-CIDP-1-clinical-trial-investigating-HYQVIA%C2%AE-as-a-maintenance-therapy-for-chronic-inflammatory-demyelinating-polyneuropathy-CIDP-at-PNS-annual-meeting/