Sanofi has received approval from Health Canada for Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antibody, to treat adult patients with moderately to severely active rheumatoid arthritis (RA).
The approval was based on data from about 2,900 adults with moderately to severely active RA who had an inadequate response to previous treatment regimens.
The fully human monoclonal antibody Kevzara binds specifically to soluble and membrane-bound IL-6 receptors, and has been shown to inhibit IL-6-mediated signalling through these receptors.
Ontario-based McMaster University department of medicine clinical professor of rheumatology Dr William Bensen said: “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.
“Kevzara represents a welcome new treatment option that works differently from the most commonly used biologics.”
RA is a systemic inflammatory disease that can affect multiple joints in the body and its inflammation manifests in the lining of the joints leading to pain, swelling and joint damage.
It impacts 70 million adults globally and approximately 300,000 people are affected in Canada alone.
Sanofi Genzyme executive vice-president and head David Meeker said: “While there have been advances in the treatment of rheumatoid arthritis, not all available therapies work for every patient and there remains an unmet need for new therapeutic options.
“The approval of Kevzara in Canada represents an important advancement in treating adult patients with moderately to severely active RA.”
Kevzara is expected to be available to patients in the country soon and will be marketed by Sanofi Genzyme.