argenx(US:ARGX)2023-03-15 16:00Drug Approval and Indications - VYVGART is the first neonatal Fc receptor (FcRn) blocker approved in the UK for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive[1]. - VYVGART is approved in the US, Europe, and the UK for treating adults with gMG who are AChR antibody positive, and in Japan for those not responding adequately to steroids or non-steroidal immunosuppressive therapies[7]. Clinical Trial Results - In the Phase 3 ADAPT trial, 68% of anti-AChR antibody positive gMG patients treated with VYVGART were responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, compared to 30% for placebo (p<0.0001)[3]. - The ADAPT trial also showed 63% of patients treated with VYVGART were responders on the Quantitative Myasthenia Gravis (QMG) scale, versus 14% for placebo (p<0.0001)[4]. - The Phase 3 ADAPT trial enrolled 167 adult patients with gMG across North America, Europe, and Japan, randomized in a 1:1 ratio to receive either VYVGART or placebo[6]. Safety and Adverse Reactions - The most common adverse reactions for VYVGART included upper respiratory tract infections (10.7% vs. 4.8% for placebo) and urinary tract infections (9.5% vs. 4.8% for placebo)[4]. Regulatory Designations and Access - VYVGART received a Promising Innovative Medicine (PIM) designation from the MHRA in November 2021 and a positive scientific opinion under the Early Access to Medicines Scheme in May 2022[5]. - argenx aims to collaborate with local authorities to ensure broad and rapid access to VYVGART for eligible patients in the UK[1]. Impact on the Myasthenia Gravis Community - The approval of VYVGART is expected to provide a new treatment option for the gMG community in the UK, potentially reducing the burden of this debilitating disease[5]. - Approximately 85% of people with myasthenia gravis progress to gMG within 24 months, with 85% of gMG patients having confirmed AChR antibodies[8].