Amsterdam, The Netherlands
VYVGART? is the first-and-only neonatal Fc receptor (FcRn) blocker authorized for sale in Canada
Approval based on the positive Phase 3 ADAPT trial (p<0.0001) showing 68% of VYVGART-treated patients were responders on the MG-ADL scale compared to 30% of placebo patients after one treatment cycle
argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Health Canada has issued a Notice of Compliance authorizing VYVGART? (efgartigimod alfa) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. With this regulatory milestone, VYVGART is the first- and-only neonatal Fc receptor (FcRn) blocker authorized for sale in Canada.
“There continues to be a significant unmet medical need for people living with gMG, who face debilitating muscle weakness and mobility issues. We are very excited by the authorization of VYVGART for sale in Canada, bringing a safe and effective treatment option to patients and clinicians that targets the underlying driver of gMG by reducing IgG autoantibodies,” said Dr. Vera Bril, Professor of Medicine (Neurology) at the University of Toronto, Director of the Neuromuscular Section, Division of Neurology, University of Toronto and University Health Network.
“Living with gMG can significantly impact a person’s independence and affect basic personal tasks, such as speaking, chewing and swallowing food, and brushing teeth and hair, and in some severe cases, it can also affect breathing. The gMG community in Canada has long awaited new effective treatment advancements for this rare condition. Today’s announcement brings new hope for people with gMG, and we look forward to seeing the important impact of this additional treatment option,” said Stacey Lintern, Chief Executive Officer, Muscular Dystrophy Canada.
The authorization of VYVGART is based on results from the global Phase 3 ADAPT trial, which were published in the July 2021 issue of The Lancet Neurology. The ADAPT trial met its primary endpoint, demonstrating that significantly more anti-AChR antibody positive gMG patients were responders on the MG-ADL scale following treatment with VYVGART compared with placebo (68% vs. 30%; p<0.0001) and on the Quantitative Myasthenia Gravis (QMG) scale (63% VYVGART vs. 14% placebo; p<0.0001).
VYVGART had a demonstrated safety profile in the ADAPT clinical trial. The most common adverse events in ADAPT were headache (29% vs 28% placebo), upper respiratory tract infection (11% vs 5% placebo), and urinary tract infection (10% vs. 5% placebo).
“Today is an important day for us as we deliver on our commitment to the gMG community to make VYVGART available to patients in Canada,” said John Haslam, General Manager argenx Canada. “For the first time, people living with gMG in Canada will have a treatment option that is targeted to the biology of their disease, which is both well-tolerated and effective in managing symptoms.”
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