EU approves Vyvgart for generalized myasthenia gravis
Argenx announced that the European Commission (EC) has granted marketing authorization for Vyvgart (efgartigimod alfa-fcab) as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive
The EC 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. 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.
There were also significantly more responders on the Quantitative Myasthenia Gravis (QMG) scale following treatment with efgartigimod compared with placebo (63% vs. 14%; p<0.0001). 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 were upper respiratory tract infections (10.7% following treatment with efgartigimod vs. 4.8% of placebo) and urinary tract infections (9.5% vs. 4.8%).
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