Trends in Anesthesiology

The U.S. Food and Drug Administration (FDA) has granted approval for Takeda’s Gammagard Liquid^® as an intravenous immunoglobulin (IVIG) therapy for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rare immune-mediated neuromuscular disorder, and Gammagard Liquid is now the only IVIG therapy approved for multiple neuromuscular disorder indications in the U.S. The approval is based on data from the Phase 3 ADVANCE-CIDP Open-Label Study, demonstrating the safety and efficacy of the medication as an IVIG therapy. It can be used as an induction dose followed by maintenance doses. The approval follows the recent FDA approval of Hyqvia^® for maintenance therapy to prevent the relapse of neuromuscular disability and impairment in patients with CIDP. Gammagard Liquid was administered in a prospective study, demonstrating a 94.4% responder rate in improving functional disability. The most common adverse reactions observed were headache, pyrexia, and anemia.

Source: asamonitor.pub/49j8nxL