Argenx SE (NASDAQ: ARGX), the U.S. partner of China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), has announced that the U.S. Food and Drug Administration (FDA) has granted approval for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Vygart Hytrulo is a subcutaneous (SC) combination of efgartigimod alfa, a human IgG1 antibody fragment marketed under the brand name Vygart, and recombinant human hyaluronidase PH20 (rHuPH20). It utilizes Halozyme’s Enhanze drug delivery technology to facilitate subcutaneous injection of biologics. Zai Lab secured the rights for the development of Vygart in Greater China from Argenx in a deal inked in 2021. In September 2023, Zai received initial approval for the drug for the treatment of generalized myasthenia gravis (MG). CIDP is another rare disease affecting an estimated 50,000 individuals, with only a fraction responding to standard corticosteroid treatments. Recently, a supplemental Biologics License Application (sBLA) for the drug was accepted for review by China’s National Medical Products Administration.- Flcube.com
