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].

Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of VYVGART® (efgartigimod alfa) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adult patients, marking a significant advancement in treatment options for this rare autoimmune disease [1][4]. Company Overview - argenx SE is a global immunology company focused on developing innovative treatments for severe autoimmune diseases, aiming to address significant unmet medical needs [2][9]. - The company has developed VYVGART, the first targeted IgG Fc-antibody fragment for CIDP, which, if approved, would be the first novel treatment for CIDP in Europe in over 30 years [2][5]. Clinical Trial Insights - The CHMP recommendation is based on positive results from the ADHERE clinical trial, which is the largest study of CIDP patients to date, involving 322 participants [3][5]. - In the ADHERE trial, 66.5% of patients treated with VYVGART showed clinical improvement, with a primary endpoint met demonstrating a 61% reduction in the risk of relapse compared to placebo [3][5]. - The trial also indicated significant functional improvements in various clinical assessment tools, with 99% of participants opting to continue in the open-label extension of the study [3][5]. Market Implications - The CHMP's positive opinion serves as a scientific recommendation for marketing authorization, with the European Commission expected to make a decision within approximately two months [4][5]. - If approved, VYVGART will be available for subcutaneous injection, providing a new treatment option for CIDP patients across all 27 EU member states, as well as Iceland, Norway, and Liechtenstein [4][5]. Disease Context - CIDP is a rare autoimmune disease affecting the peripheral nervous system, leading to symptoms such as fatigue, muscle weakness, and loss of sensation, which can significantly impair daily functioning [7]. - There are an estimated 31,413 individuals living with CIDP in the European Union, highlighting the need for effective treatment options [7].