Takeda Pharmaceutical Co. Ltd. (TAK) announced promising long-term results from its Phase 3 ADVANCE-CIDP 3 clinical trial of HYQVIA in patients suffering from Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
CIDP is an acquired, immune-mediated disorder that affects the peripheral nervous system, leading to progressive, symmetric weakness in both distal and proximal limbs, and impaired sensory functions in the extremities.
This long-term extension study evaluates the safety and efficacy of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in CIDP patients. According to the company, the ADVANCE-CIDP 3 trial is the most extended study conducted in the context of clinical trials for CIDP to date.
Results indicated favorable long-term safety and tolerability for HYQVIA, featuring a low relapse rate, thus supporting its use as a maintenance therapy for CIDP.
The company plans to present these findings through a poster session on June 23, 2024, at the Peripheral Nerve Society (PNS) Annual Meeting in Montreal, Canada.
HYQVIA is the first and only facilitated subcutaneous immunoglobulin (fSCIG) for CIDP. This year, the U.S. Food and Drug Administration approved it as a maintenance therapy for adults with CIDP, and the European Commission approved it for patients of all ages with CIDP, provided stabilization with intravenous immunoglobulin (IVIG) is achieved.
Kristina Allikmets, Senior Vice President and Head of Research & Development for Takeda's Plasma-Derived Therapies Business Unit, stated, "The long-term data from the ADVANCE-CIDP 3 clinical trial allow us to further characterize the safety, efficacy, and tolerability profile of HYQVIA and reinforce its role as a long-term, up-to once-monthly maintenance treatment for this complex, chronic condition."
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