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

Approved stamps for sarilumab for rheumatoid arthritis

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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.

About rheumatoid arthritis

Rheumatoid arthritis is an autoimmune disease with hallmark symptoms of inflammation and resulting pain. It is a disease process (like cancer or diabetes) where the body’s immune system mistakenly attacks its own healthy joints. It is a relatively common disease-approximately 300,000 or 1 in 100 Canadians get it-and is often devastating to a person’s body if not treated properly. The disease process causes swelling and pain in and around joints and can affect the body’s organs, including the eyes, lungs, and heart. Rheumatoid arthritis most commonly affects the hands and feet. Other joints often affected include the elbows, shoulders, neck, jaw, ankles, knees, and hips. When moderate to severe, the disease reduces a person’s life span by as much as a dozen years.

Interestingly, rheumatoid arthritis affects women two out of three times more often than men, and like many forms of inflammatory arthritis, it tends to strike people in the prime of their lives; most commonly, people are diagnosed between the ages of 20 and 50, though rheumatoid arthritis can strike at any time-people of every age from toddlers to senior citizens have been diagnosed with the disease.

To learn more about rheumatoid arthritis, please click here.