Argenx announces EC approval of subcutaneous VYVGART for gMG

argenx announced that the European Commission approved SC injectable VYVGART as an add-on to standard therapy for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive. The EC previously approved VYVGART IV in August 2022. Following this decision, VYVGART is now approved in Europe for both IV and self-administered SC use. The approval is applicable to all 27 European Union Member States plus Iceland, Norway and Liechtenstein. argenx will work with local health authorities to secure patient access for VYVGART SC in the region. The EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use and is based on positive results from the Phase 3 ADAPT-SC study. ADAPT-SC established the efficacy of VYVGART SC by demonstrating a reduction in anti-AChR antibody levels comparable to VYVGART IV in adult gMG patients. ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of VYVGART IV in Europe in August 2022.