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argenx Highlights Data Showing Patient Impact Across Multiple Immunology Programs at 2024 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting and Myasthenia Gravis Foundation of America Scientific Sessions
ARGXargenx(ARGX) GlobeNewswire News Room·2024-10-15 05:00

VYVGART and VYVGART Hytrulo Efficacy and Safety - VYVGART demonstrates rapid, deep, and sustained responses in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) [4] - More than 50% of gMG patients show substantial and sustained reduction in steroid use after VYVGART initiation [1] - VYVGART Hytrulo shows sustained functional benefit in motor function and muscle strength in CIDP patients, regardless of prior treatment [5] - VYVGART has a consistent and favorable safety profile with over 8,000 patient years of safety data [6] Real-World Data and Clinical Studies - Real-world data show 55% of gMG patients reduced corticosteroid use by ≥5 mg/day one year post VYVGART initiation [5] - 42% of gMG patients achieved steroid doses of ≤5mg/day after one year of VYVGART treatment [5] - Phase 3 studies are ongoing for seronegative and ocular MG populations, showing consistent and clinically meaningful improvements [5] Pipeline Expansion in Neurology - argenx is advancing empasiprubart for multifocal motor neuropathy (MMN) and ARGX-119 for amyotrophic lateral sclerosis (ALS) and congenital myasthenic syndromes (CMS) [9] - Phase 2 ARDA study shows empasiprubart reduces IVIg retreatment risk by 91% and improves grip strength in MMN patients [10] - A Phase 3 study of empasiprubart in MMN is set to start by the end of 2024 [10] Immunology Pipeline Highlights - argenx is evaluating empasiprubart in multiple autoimmune indications, including delayed graft function, dermatomyositis, and CIDP [32] - ARGX-119, a muscle-specific kinase (MuSK) agonist, is being developed for neuromuscular diseases [34] - The company continues to expand its neurology pipeline to deliver transformative outcomes for patients [3] Market and Regulatory Position - VYVGART is the first approved FcRn blocker in the US, EU, China, and Canada for gMG treatment [28] - VYVGART Hytrulo is the first-and-only approved FcRn blocker administered by subcutaneous injection [29] - argenx is committed to improving the lives of patients with severe autoimmune diseases through its immunology pipeline [38]