Argenx announces fda acceptance of supplemental biologics license application with priority review for vyvgart hytrulo in chronic inflammatory demyelinating polyneuropathy

Prescription drug user fee act (pdufa) target action date is june 21, 2024 if approved, vyvgart ® hytrulo will be the first neonatal fc receptor (fcrn) blocker to treat cidp february 20, 2024, 7:00 am cet amsterdam, the netherlands – argenx se (euronext & nasdaq: argx), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the u.s. food and drug administration (fda) has accepted for priority review a supplemental biologics license application (sbla) for vyvgart hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (cidp). the application has been granted a pdufa target action date of june 21, 2024.
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