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Health Canada Approves Kevzara for Rheumatoid Arthritis
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Health Canada has approved Kevzara for the treatment of patients with rheumatoid arthritis who had an inadequate response or intolerance to a biologic or non-biologic disease-modifying antirheumatic drug, according to a company press release.
“With Kevzara, we have a promising new therapy in Canada, which has shown clinically meaningful and statistically significant improvements in adult patients with moderately to severely active rheumatoid arthritis,” William Bensen, MD, clinical professor of rheumatology in the Department of Medicine at McMaster University in Ontario, said in the release. “Kevzara represents a welcome new treatment option that works differently from the most commonly used biologics.”
Health Canada recommended Kevzara (sarilumab, Sanofi and Regeneron) — an interleukin-6 inhibitor — as a 200-mg subcutaneous dose every 2 weeks; however, the dose can be reduced to 150 mg if there are laboratory abnormalities. The approval was based on data from the SARIL-RA trial of 2,900 adults with rheumatoid arthritis (RA). Of these patients, 1,743 showed clinically meaningful improvement. However, patients also showed an increased risk for infection that may lead to hospitalization or death. The most frequent adverse reactions were neutropenia (6% to 10%), increased alanine aminotransferase (4% to 5%), injection site erythema (3% to 4%) and upper respiratory tract infections (3%).
In the United States, the resubmission of the biologics license application for sarilumab to the FDA is expected to occur in the first quarter of 2017, according to the release. In July 2016, the European Medicines Agency accepted for review a marketing authorization application for sarilumab and a decision is expected in 2017.
“While there have been advances in the treatment of rheumatoid arthritis, not all available treatments work for every patient and there remains an unmet need for new therapeutic options,” David Meeker, MD, executive vice president and head of Sanofi Genzyme, said. “The approval of Kevzara in Canada represents an important advancement in treating adult patients with moderately to severely active RA.”
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