Argenx Gets European Marketing Authorization For Neuromuscular Disorder Candidate

The European Commission (EC) has granted marketing authorization for Argenx’s ARGX lead asset VYVGART (efgartigimod alfa-fcab) as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG).

The regulatory approval is supported by the results from the global Phase 3 ADAPT trial that met its primary endpoint.

VYVGART has demonstrated 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.

Tim Van Hauwermeiren, Chief Executive Officer, commented: "Now, for the first time, people living with gMG in the EU will have a treatment option that is targeted to the biology of their disease, well-tolerated, and effective in managing symptoms. We are proud to bring the first-and-only approved FcRn blocker to the EU on the heels of our U.S. and Japan launches, and remain steadfast in our mission to make VYVGART available to patients across the globe.”

The marketing approval is appropriate to all 27 European Union (EU) Member States plus Iceland, Norway and Liechtenstein.

The company remains on track to launch VYVGART in Canada, China through its collaboration with Zai Lab.

Price Action : Argenx shares are trading around 1 percent higher at $376.88 on Thursday at the time of publication.