FDA approval of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for chronic inflammatory demyelinating polyneuropathy.-argenx

Vyvgart Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. It is the first and only neonatal Fc receptor (FcRn) blocker approved for the treatment of CIDP.

“argenx continues to pursue our ambition to turn science into solutions for patients with severe autoimmunity,” said Luc Truyen M.D., Ph.D., Chief Medical Officer, argenx. “Patients have been waiting, and today argenx is delivering the first innovative treatment for CIDP in more than 30 years.Vyvgart Hytrulo is a precision tool that has been shown to drive meaningful benefits for patients. Today’s FDA approval means that CIDP patients have a transformational new treatment option and further affirms the therapeutic profile of Vyvgart Hytrulo and the potential of FcRn blockade in IgG-mediated autoimmune diseases.”

The FDA approval is based on the ADHERE Study, the largest clinical trial to date studying CIDP. In the ADHERE study, 69% (221/322) of patients treated with Vyvgart Hytrulo, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function and strength. ADHERE met its primary endpoint (p<0.0001) demonstrating a 61% reduction (hr: 0.39 95% ci: 0.25; 0.61) in the risk of relapse versus placebo. ninety-nine percent of trial participants elected to participate in the adhere open-label extension. the safety results were generally consistent with the known safety profile of vyvgart in previous clinical studies and real-world use.>