JointHealth™ express   April 3, 2017

Health Canada approves sarilumab (Kevzara®) for the treatment of rheumatoid arthritis

Sarilumab (Kevzara®) is now approved in Canada to treat moderate to severely active rheumatoid arthritis

Health Canada has approved a new treatment for Canadians with moderate to severely active rheumatoid arthritis. Sarilumab (Kevzara®) was issued its Notice of Compliance on January 12, 2017. Click here to view Health Canada’s Summary Basis of Decision.

Sarilumab (Kevzara®), an interleukin-6 receptor antagonist, has been approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate reponse or intolerance to one or more biologic or non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

Sarilumab (150 mg/1.14 mL or 200 mg/1.14 mL) is presented as a solution for injection in a single-dose pre-filled syringe. In addition to the medicinal ingredient, the solution contains arginine, histidine, polysorbate 20, sucrose, and water for injection.

For more information, refer to the Clinical, Non-Clinical, and Quality (Chemistry and Manufacturing) Basis for Decision sections.

Additional information may be found in the Kevzara Product Monograph, approved by Health Canada and available through the Drug Product Database.