Research & Development
argenx receives FDA priority review for VYVGART Hytrulo in CIDP
20 February 2024 -

Immunology company argenx SE (Euronext Brussels:ARGX) (Nasdaq:ARGX) reported on Tuesday that the US 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 PDUFA target action date is set for 21 June 2024.

CIDP is a rare and serious autoimmune disease of the peripheral nervous system, with symptoms including fatigue, muscle weakness and a loss of feeling in the arms and legs that can get worse over time or may come and go. Without treatment, one-third of people living with CIDP will need a wheelchair.

The application is backed by data from the ADHERE study, demonstrating a 61% lower relapse risk with VYVGART Hytrulo compared to placebo. In the open-label Stage A of the study, two-thirds (67%) of patients showed evidence of clinical improvement following treatment with VYVGART Hytrulo.