TOKYO (dpa-AFX) - Takeda Pharmaceutical Co. Ltd. (TAK) announced Tuesday favorable long-term data from the Phase 3 ADVANCE-CIDP 3 clinical trial of HYQVIA in Patients with Chronic Inflammatory Demyelinating Polyneuropathy or CIDP.
CIDP is an acquired, immune-mediated condition affecting the peripheral nervous system that is characterized by progressive, symmetric weakness in distal and proximal limbs and impaired sensory function in the extremities.
The long-term extension study evaluates the safety and efficacy of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with CIDP. The ADVANCE-CIDP 3 clinical trial is the longest extension study ever performed within context of a clinical trial in CIDP to date, the company noted.
The results showed favorable long-term safety and tolerability of HYQVIA, and a low relapse rate, supporting its use as maintenance treatment for CIDP.
The company plans to present these findings in 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, approved earlier this year by the U.S. Food and Drug Association as maintenance therapy in adults with CIDP and by the European Commission for patients of all ages with CIDP post-stabilization with intravenous immunoglobulin (IVIG).
Kristina Allikmets, senior vice president and head of Research & Development for Takeda's Plasma-Derived Therapies Business Unit, said, '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 reinforces its role as a long-term, up-to once monthly maintenance treatment for this complex, chronic condition.'
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