Takeda (TAK) said that the European Commission approved Hyqvia as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy or CIDP after stabilization with intravenous immunoglobulin therapy or IVIG.
The approval expands Takeda's Portfolio of Differentiated Immunoglobulin Therapies for Patients with Neuroimmunological Disorders.
Takeda stated that Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] becomes the only Facilitated Subcutaneous Immunoglobulin, offering patients an up to once-monthly treatment option.
Takeda previously announced a positive opinion from the Committee for Medicinal Products for Human Use on December 15, 2023 and approval as a maintenance therapy for adults with CIDP by the U.S. Food and Drug Administration on January 16, 2024.
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.
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