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Government Health Agency News

FDA

Vyvgart Hytrulo approved for CIDP

July 1, 2024

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FDA has approved efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). Efgartigimod alfa is a human IgG1 antibody fragment that binds to the neonatal Fc receptor, resulting in reduction of circulating IgG. Hyaluronidase increases permeability of subcutaneous tissue by depolymerizing hyaluronan. Approval was based on results from the phase 3 ADHERE study.

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