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Pharmaceuticals / Submissions and Approvals

Sanofi and Regeneron Receive FDA Approval for Kevzara in Rheumatoid Arthritis

May 26, 2017

The FDA approved Kevzara (sarilumab) for treatment of moderately to severely active rheumatoid arthritis in adult patients who have had an inadequate response to other antirheumatic drugs, such as methotrexate.

Kevzara is an antibody that binds to the interleukin-6 receptor, and has been shown to inhibit IL-6R mediated signaling. IL-6 is a cytokine in the body that, in excess and over time, can contribute to the inflammation associated with rheumatoid arthritis.

Kevzara may be used as monotherapy or in combination with methotrexate or other conventional treatments. The recommended dosage is 200 mg subcutaneous injection every two weeks, which can be self-administered. Kevzara was approved in Canada in January 2017.

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