Kevzara receives first approval in Canada

Regulatory decisions for Kevzara are anticipated in the US and European Union later this year.

Regeneron Pharmaceuticals and Sanofi have announced that Health Canada approved Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antibody, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic disease-modifying anti-rheumatic drugs (DMARDs)

"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 RA," said Dr William Bensen, Clinical Professor of Rheumatology, Department of Medicine at McMaster University, Ontario, Canada. "Kevzara represents a welcome new treatment option that works differently from the most commonly used biologics."

Kevzara is a fully human monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6 receptors, and has been shown to inhibit IL-6-mediated signalling through these receptors. Local production of IL-6 by synovial and endothelial cells in joints affected in chronic inflammatory disease, such as RA, may play an important role in development of the inflammatory processes.

"While there have been advances in the treatment of RA, not all available therapies work for every patient and there remains an unmet need for new therapeutic options," said David Meeker, EVP and Head of Sanofi Genzyme. "The approval of Kevzara in Canada represents an important advancement in treating adult patients with moderately to severely active RA."

The Health Canada approval of Kevzara was based on data from the global SARIL-RA clinical trial program which includes approximately 2,900 adults with moderately to severely active RA who had an inadequate response to previous treatment regimens. Kevzara demonstrated clinically-meaningful improvements, either as monotherapy or in combination with conventional DMARDs, including methotrexate, in reducing signs and symptoms, improving physical function, and inhibiting radiographic progression of structural damage of RA in approximately 1,743 patients with moderately to severely active RA. Kevzara should be used in combination with methotrexate or other traditional DMARDs, or may be given as monotherapy in cases of intolerance or contraindication to methotrexate or DMARDs. The recommended dose of Kevzara is 200 mg once every 2 weeks given as a subcutaneous injection; dosage can be reduced from 200 mg to 150 mg once every 2 weeks to help manage certain laboratory abnormalities.

Kevzara is expected to be available to patients in Canada soon and there will be a patient support program at the time of product availability. The companies are committed to helping patients who are prescribed Kevzara gain access to the medicine and receive the support they may need. In Canada, Kevzara will be marketed by Sanofi Genzyme, the specialty care global business unit of Sanofi.