argenx SE 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. The company chose to use a priority review voucher to accelerate review of submission because CIDP patients have long been waiting for new treatment options.

FDA's acceptance of the sBLA represents an important milestone in continued drive to bring novel treatments for rare, autoimmune diseases, and a significant step forward for people whose lives have been profoundly impacted by this devastating disease. The sBLA is supported by data from the ADHERE study, the largest clinical trial of CIDP to date, evaluating the safety and efficacy of subcutaneously administered VYVGART HytrulO in adults with CIDP. The study met its primary endpoint (p=0.000039), demonstrating a 61% lower risk of relapse (HR: 0.39 95% CI: 0.25; 0.61) 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. Given the mechanism of action of VYVGART Hytrula as an FcRn blocker, the clinical results established that IgG autoantibodies play a significant role in the underlying biology of CIDP. VYVGART Hytrulus was well-tolerated with a safety profile that is consistent with prior clinical trials and the known profile of VYVGART®?.

After completing ADHERE, 99% of eligible patients (226/228) continued to the ADHERE?? open-label extension study. It may be marketed under different proprietary names following approval in other regions.

What is VYVGART®? HYTRULO (efgartigimod Alfa and hyaluronidases-qvFC). VYVGART HYTRULO is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).