argenx SE (ARGX), a Dutch immunology company, Friday announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use or CHMP has recommended European Commission approval for Subcutaneous Efgartigimod to treat Generalized Myasthenia Gravis or gMG.<\/p>\n
The European Commission’s decision on marketing authorization application or MAA is expected within approximately 60 days.<\/p>\n
gMG is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness.<\/p>\n
The positive opinion is for the subcutaneously or SC injectable formulation of efgartigimod as an add on to standard therapy for the treatment of adult patients with gMG who are anti acetylcholine receptor or AChR antibody positive.<\/p>\n
The recommendation is based on Phase 3 ADAPT-SC study demonstrating noninferior total IgG reduction at day 29 with SC administered efgartigimod, compared to intravenous or IV administration<\/p>\n