Core Viewpoint - The European Commission has approved VYVGART® (efgartigimod alfa) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), marking a significant advancement in therapy options for this rare autoimmune disease [1][4][5]. Company Overview - argenx SE is a global immunology company focused on developing treatments for severe autoimmune diseases, with VYVGART SC being the first therapy approved for CIDP in over 30 years [5][11]. - The company aims to translate immunology breakthroughs into a portfolio of novel antibody-based medicines and is actively working on multiple severe autoimmune diseases [11]. Product Details - VYVGART SC is administered as a subcutaneous injection and is available in vials or prefilled syringes, allowing for administration by patients, caregivers, or healthcare professionals [1]. - The treatment regimen starts with weekly doses, which can be adjusted based on clinical evaluation [1]. Clinical Trial Insights - The approval is based on the ADHERE clinical trial, the largest study of CIDP patients to date, where 66.5% of patients treated with VYVGART SC showed clinical improvement [4][7]. - The trial demonstrated a 61% reduction in the risk of relapse compared to placebo, with a primary endpoint met (p<0.0001) [4][8]. Patient Impact - CIDP is a debilitating condition affecting mobility and sensory functions, with 85% of patients requiring ongoing treatment and nearly 88% experiencing residual impairment [3][9]. - The introduction of VYVGART SC is seen as a major step forward for the patient community, providing a targeted therapy that addresses a key mechanism of the disease [2][4]. Regulatory Approval - The European Commission's approval applies to all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway, with efforts underway to ensure patient access [5][6].