Vyvgart is the first-and-only neonatal Fc receptor(FcRn) blocker authorized for sale in Canada for for the treatment of generalized myasthenia gravis

“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 III ADAPT trial, which were published in the July 2021 issue of The Lancet Neurology (previously cited). 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).