EC approves Vyvgart for the treatment of gMG
Belgo-Dutch autoimmune diseases specialist argenx (Nasdaq: ARGX) has announced that the European Commission (EC) has approved Vyvgart (efgartigimod alfa-fcab) as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
The approval is applicable to all European Union (EU) member states plus Iceland, Norway and Liechtenstein. Following the news, shares of argenx rose by 2% to 365.50 euros.
“Now, for the first time, people living with gMG in the European Union (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 US and Japan launches, and remain steadfast in our mission to make Vyvgart available to patients across the globe," said Tim Van Hauwermeiren, chief executive of argenx.
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