argenx Announces FDA Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy

Core Insights - The FDA has approved VYVGART Hytrulo as the first and only neonatal Fc receptor (FcRn) blocker for treating chronic inflammatory demyelinating polyneuropathy (CIDP), marking a significant advancement in treatment options for this condition [2][3][5] - VYVGART Hytrulo represents the first novel mechanism of action for CIDP in over 30 years, providing a new therapeutic option for patients who have been waiting for innovative treatments [3][4] - The approval is based on the ADHERE Study, which demonstrated that 69% of patients treated with VYVGART Hytrulo showed clinical improvement, with a 61% reduction in the risk of relapse compared to placebo [5][16] Company Overview - Argenx SE is a global immunology company focused on developing treatments for severe autoimmune diseases, with a commitment to improving patient lives [2][19] - The company has developed VYVGART Hytrulo, which combines efgartigimod alfa and hyaluronidase-qvfc, facilitating subcutaneous injection delivery of biologics [17] - Argenx is also evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier-stage experimental medicines [19] Treatment Context - CIDP is a rare and debilitating autoimmune disease affecting the peripheral nervous system, with significant impacts on patients' mobility and quality of life [3][18] - Current treatment options have been limited to corticosteroids and plasma-derived therapies, which can be burdensome for patients [5][4] - The introduction of VYVGART Hytrulo provides a new, safe, and effective treatment option that may alleviate some of the treatment burdens faced by CIDP patients [5][4] Clinical Study Insights - The ADHERE trial was the largest clinical trial to date for CIDP, enrolling 322 adult patients and demonstrating significant clinical benefits from VYVGART Hytrulo [5][16] - The trial's primary endpoint was met with a statistically significant reduction in relapse risk, affirming the efficacy of VYVGART Hytrulo in treating CIDP [5][16] Patient Access and Support - VYVGART Hytrulo is expected to be available for patients in the U.S. immediately, with a patient support program, My VYVGART Path, established to assist with access and education [7][19] - The annual out-of-pocket cost for patients is expected to be comparable to existing treatments for CIDP and generalized myasthenia gravis [7]