Argenx's VYVGART Hytrulo Granted Priority Review By FDA For CIDP

(RTTNews) - argenx SE (ARGX) said that the U.S. Food and Drug Administration has accepted for priority review a supplemental Biologics License Application or sBLA for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy or CIDP. The application has been granted a Prescription Drug User Fee Act or PDUFA target action date of June 21, 2024.

The sBLA is supported by data from the ADHERE study, evaluating the safety and efficacy of subcutaneously administered VYVGART Hytrulo in adults with CIDP. The study met its primary endpoint, demonstrating a 61% lower risk of relapse with VYVGART Hytrulo compared to placebo. In the open-label Stage A of the study, 67% of patients showed evidence of clinical improvement (ECI) following treatment with VYVGART Hytrulo.

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system.

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