Posted by Michael Wonder on 16 Jan 2024
US FDA approves Takeda’s HyQvia as maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy
16 January 2024 - Approval based on Phase 3 ADVANCE-CIDP 1 study demonstrating a statistically significant difference in relapse rate in favour of HyQvia versus placebo at 6 months.
Takeda today announced that the US FDA has approved HyQvia [immune globulin infusion 10% (human) with recombinant human hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults.
