MHRA(UK) approves Vyvgart as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis who are AChR antibody positive.- argenx.
argenx a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Vyvgart (efgartigimod alfa-fcab) 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 III ADAPT trial, which were published in the July 2021 issue of The Lancet Neurology (previously cited). 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 (MG-ADL) scale following treatment with efgartigimod compared with placebo (68% vs. 30%; p<0.0001). 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..></0.0001).>
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