Argenx's Vyvgart Authorized For Sale In Canada For Generalized Myasthenia Gravis

(RTTNews) - Health Canada has issued a Notice of Compliance authorizing Vyvgart (efgartigimod alfa) for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive, argenx SE (ARGX) said in a statement Thursday.

Vyvgart is the first-and-only neonatal Fc receptor (FcRn) blocker authorized for sale in Canada.

The approval was based on the positive Phase 3 ADAPT trial showing 68% of Vyvgart-treated patients were responders on the myasthenia gravis -ADL scale compared to 30% of placebo patients after one treatment cycle.

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