argenx SE announces that Health Canada has issued a Declaration of Compliance approving VYVGART (efgartigimod alfa) for the treatment of generalized myasthenia gravis (GMG) in adult patients with positive anti-acetylcholine receptor (AChR) antibodies. With this regulatory milestone, VYVGART is the first and only neonatal Fc receptor (FcRn) inhibitor approved for sale in Canada. The approval of VYVGART is based on results from the global Phase 3 ADAPT trial published in the July 2021 issue of The Lancet Neurology.
The ADAPT study met its primary endpoint and demonstrated that significantly more anti-AChR antibody-positive MGG patients responded on the MG-ADL scale after treatment with VYVGART compared to placebo (68% vs. 30%; p
The safety profile of VYVGART was demonstrated in the ADAPT clinical trial. The most common adverse reactions in the ADAPT trial were headache (29% versus 28% for placebo), upper respiratory tract infection (11% versus 5% for placebo), and urinary tract infection (10% versus 5% for placebo). .
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