Posted by Michael Wonder on 01 Feb 2017
Sanofi and Regeneron announce first approval of Kevzara (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients by Health Canada
1 February 2017 - Regulatory decisions for Kevzara are anticipated in the United States and European Union later this year.
Sanofi and Regeneron Pharmaceuticals today announced that Health Canada approved Kevzara (sarilumab), an interleukin-6 receptor antibody, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more biologic or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
The Health Canada approval of Kevzara was based on data from approximately 2,900 adults with moderately to severely active rheumatoid arthritis who had an inadequate response to previous treatment regimens, including seven studies from the global SARIL-RA clinical program. 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 rheumatoid arthritis in approximately 1,743 patients with moderately to severely active rheumatoid arthritis.
