Sanofi and Regeneron Win FDA Approval of Kevzara for Rheumatoid Arthritis

“Today’s approval…not only underscores our ongoing commitment to making a difference in the lives of patients, but also demonstrates our drive to accelerate science and medicine in immunology.” So said Sanofi Chief Executive Officer Olivier Brandicourt as Sanofi and Regeneron Pharmaceuticals announced FDA approval of Kevzara® (sarilumab) for the treatment of adults with moderate to severe rheumatoid arthritis (RA).

Kevzara is approved for those who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX).  The drug is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), 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 RA.

RA is a chronic inflammatory autoimmune disease in which the immune system attacks the tissues of the joints, causing inflammation, pain, and eventually joint damage and disability. RA affects approximately 1.3 million Americans, with nearly 75 percent being women. It most often strikes people between 30 and 60 years old; however, it can occur in adults at any age.

In the U.S., Kevzara will be marketed by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi. Kevzara was approved in Canada in January 2017. In April 2017, the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the marketing authorization of Kevzara recommending its approval for use in adult patients with moderately to severely active RA. A final decision on the Marketing Authorization Application (MAA) for Kevzara in the European Union will be made by the European Commission in the coming months. The companies are also seeking approvals in a number of other countries globally. (Source: Sanofi Genzyme Website, 22 May, 2017)