argenx announces FDA acceptance of supplemental biologics license application with priority review for Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy

argenx

20 February 2024 - Prescription Drug User Fee Act target action date is 21 June 2024.

argenx today announced that the US FDA has accepted for priority review a supplemental biologics license application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy.

Read argenyx press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Medicine , US , Priority review , Dossier