European Commission approved SC injectable Vyvgart. (efgartigimod alfa) as an add-on to standard therapy for the treatment of generalized myasthenia gravis

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 (EU) Member States plus Iceland, Norway and Liechtenstein. argenx will work with local health authorities to secure patient access for Vyvgart SC in the region.

About Phase III ADAPT-SC Trial: The Phase III ADAPT-SC trial was a multicenter, randomized, open-label, parallel-group study evaluating the noninferiority of the pharmacodynamic (PD) effect of Vyvgart SC compared with Vyvgart IV in adult patients with gMG. The pharmacodynamic effect was measured by percent change from baseline for both total IgG and AChR autoantibody levels at day 29. Safety, clinical efficacy, immunogenicity and pharmacokinetics (PK) were also assessed. A total of 110 adult patients with gMG in North America, Europe and Japan enrolled in the ADAPT-SC trial. Patients were randomized in a 1:1 ratio to receive Vyvgart IV or SC for one treatment cycle consisting of four doses at once-weekly intervals. The total study duration was approximately 12 weeks, including seven weeks of follow-up after the treatment cycle. At the completion of ADAPT-SC, patients had the opportunity to roll-over to ADAPT-SC+, an open-label extension study.