Posted by Michael Wonder on 17 Dec 2023
Takeda receives positive CHMP opinion for Hyqvia as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy
15 December 2023 - Positive opinion based on Phase 3 ADVANCE-CIDP 1 study, which met its primary endpoint demonstrating a statistically significant reduction in relapse rate.
Takeda today announced the EMA's CHMP has recommended the approval of Hyqvia [immune globulin infusion 10% (human) with recombinant human hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy as maintenance therapy after stabilisation with intravenous immunoglobulin therapy.
