argenx(ARGX) Newsfilter·2024-12-27 06:00Core Insights - Japan's Ministry of Health, Labour and Welfare (MHLW) has approved VYVDURA for at-home self-injection for adults with chronic inflammatory demyelinating polyneuropathy (CIDP), marking Japan as the first country globally to provide access to this treatment across three indications [1][4] Company Overview - Argenx SE is a global immunology company focused on improving the lives of individuals suffering from severe autoimmune diseases, with a commitment to developing novel antibody-based medicines [17] - The company has developed the first approved neonatal Fc receptor (FcRn) blocker, efgartigimod, which is being evaluated for multiple serious autoimmune diseases [17] Product Details - VYVDURA is a subcutaneous injection combining efgartigimod alfa and recombinant human hyaluronidase PH20, designed for the treatment of CIDP [14][15] - The product allows for a convenient 30-to-90 second self-injection at home, providing a novel therapy option for CIDP patients [2][3] Clinical Evidence - The approval of VYVDURA is based on the ADHERE Study, the largest clinical trial for CIDP, where 69% of patients showed clinical improvement, and the trial met its primary endpoint with a 61% reduction in relapse risk compared to placebo [3][13] - The safety profile of VYVDURA was consistent with previous studies, and 99% of trial participants opted to continue in the open-label extension [3] Market Context - CIDP is a rare and debilitating disease with limited treatment innovation over the past 30 years, affecting mobility and sensory functions, and leading to significant disability in patients [2][20] - Approximately 85% of CIDP patients require ongoing treatment, highlighting the need for effective therapies like VYVDURA [2]