Argenx announces MHRA approval of VYVGART

argenx announced that the UK Medicines and Healthcare products Regulatory Agency has granted marketing authorization for VYVGART as an add-on to standard therapy for the treatment of adult patients with gMG who are AChR antibody positive. The MHRA approval of VYVGART is based on results from the global Phase 3 ADAPT trial, which were published in the July 2021 issue of The Lancet Neurology. The ADAPT trial met its primary endpoint, demonstrating that significantly more anti-AChR antibody positive gMG patients were responders on the Myasthenia Gravis Activities of Daily Living scale following treatment with efgartigimod compared with placebo. Responders were defined as having at least a two-point reduction on the MG-ADL scale sustained for four or more consecutive weeks during the first treatment cycle. There were also significantly more responders on the Quantitative Myasthenia Gravis scale following treatment with efgartigimod compared with placebo. Responders were defined as having at least a three-point reduction on the QMG scale sustained for four or more consecutive weeks during the first treatment cycle. VYVGART had a demonstrated safety profile in the ADAPT clinical trial. The most commonly reported adverse reactions that occurred more frequently with VYVGART than placebo were upper respiratory tract infections and urinary tract infections.