Health Canada approves Kevzara (sarilumab) as a treatment for moderately to severely active rheumatoid arthritis.- Sanofi + Regeneron.

Sanofi and Regeneron Pharmaceuticals, Inc. 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).

The resubmission of the sarilumab Biologics License Application (BLA) to the FDA is expected in the first quarter of 2017. This resubmission is subject to successful completion of an inspection by FDA of Sanofi’s Le Trait fill and finish facility, with an anticipated action date in the second quarter. The European Medicines Agency accepted for review the Marketing Authorization Application for sarilumab in July 2016 and a decision is expected later this year.