Takeda has announced that the FDA has approved HYQVIA® for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as a maintenance therapy to prevent relapse in adults. This approval allows HYQVIA, an FDA-approved combination of immunoglobulin (IG) and hyaluronidase, to be used in the treatment of CIDP, expanding its use beyond primary immunodeficiency (PI), for which it was first approved in the U.S. in 2014.

HYQVIA is a facilitated subcutaneous immunoglobulin (SCIG) infusion that can be administered up to once a month, facilitated by the hyaluronidase component, which aids the subcutaneous dispersion and absorption of IG. The therapy can be delivered by healthcare professionals or self-administered by trained patients or caregivers, providing flexibility and convenience.

Giles Platford, president of Takeda’s Plasma-Derived Therapies Business Unit, noted the significance of this approval, highlighting the company’s aim to offer more personalized treatment options for adults with CIDP, a debilitating neurological condition. Platford also expressed the hope that this would be the first of many global approvals for HYQVIA.

The approval is based on results from the ADVANCE-CIDP 1 and ADVANCE-CIDP 3 studies, which assessed the efficacy and safety of HYQVIA in adults. The primary efficacy analysis involved 122 adults with a confirmed CIDP diagnosis who had been on stable IVIG therapy. The analysis presented a significant difference in relapse rates between the HYQVIA and placebo groups, demonstrating the superiority of HYQVIA in preventing CIDP relapse.

CIDP is a rare, immune-mediated disorder that affects the peripheral nervous system, typically characterized by weakness, sensory loss, loss of reflexes, and difficulty walking. Due to overlapping symptoms with other conditions, CIDP can be challenging to diagnose and treat.

Source link: http://www.businesswire.com/news/home/20240115984065/en/U.S.-FDA-Approves-Takeda%E2%80%99s-HYQVIA%C2%AE-as-Maintenance-Therapy-in-Adults-with-Chronic-Inflammatory-Demyelinating-Polyneuropathy-CIDP

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.