European Commission (EC) approved Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP)

Takeda previously announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 15, 2023 and approval as a maintenance therapy for adults with CIDP by the FDA on January 16, 2024.

As the first and only facilitated subcutaneous immunoglobulin (fSCIG) for CIDP, Hyqvia offers the potential for patients to infuse up to once monthly (every two, three or four weeks), as the hyaluronidase component facilitates the dispersion and absorption of large immunoglobulin (IG) volumes in the subcutaneous space between the skin and the muscle. Hyqvia can be administered by a healthcare professional or self-administered in the comfort of a patient’s own home after appropriate training.

“Following the FDA approval of the Hyqvia CIDP indication in January 2024, the EC’s approval of Hyqvia for CIDP is a critical step towards giving people in the EU living with CIDP access to a maintenance treatment with proven efficacy that can be administered up to once monthly, at-home or in-office” said Kristina Allikmets, senior vice present and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit.