Takeda's Hyqvia Secures European Nod for Maintenance Therapy in Patients

After stabilization with intravenous immunoglobulin therapy, Takeda announced that the European Commission granted approval to Hyqvia (Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase) as maintenance therapy for patients of all ages with chronic inflammatory demyelinating polyneuropathy. Takeda recently declared a positive assessment from the Board for Restorative Items for Human Use on December 15, 2023 and endorsement as a support treatment for grown-ups with CIDP by the US Food and Medication Organization on January 16, 2024.

As the first and only facilitated subcutaneous immunoglobulin 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 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, as per pharmabiz.

“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. “This expanded indication for HYQVIA also reflects Takeda’s commitment to bring the benefits of our immunoglobulin therapies to people with neuroimmunological disorders and provide treatment options that have the potential to positively impact their lives and elevate the standard of care.”

Impaired sensory function in the extremities and progressive, symmetric weakness in the distal and proximal limbs are hallmarks of CIDP, an acquired immune-mediated condition affecting the peripheral nervous system.