The U.S. Food and Drug Administration (FDA) has approved Sanofi’s and Regeneron Pharmaceuticals’s Kevzara (sarilumab) 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 disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX).
Sanofi explained in its press release that Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), and has been shown to inhibit IL-6R mediated signaling.1 IL-6 is a cytokine in the body that, in excess and over time, can contribute to the inflammation associated with RA.
“In the clinical trial program, sarilumab demonstrated statistically significant, clinically-meaningful improvements in adult patients with rheumatoid arthritis by reducing signs and symptoms, improving physical function, and resulting in significantly less radiographic progression of structural damage of RA,” said Alan Kivitz, Founder and Medical Director of the Altoona Center for Clinical Research. “This is important because not all currently available treatments work in all patients, and some patients may spend years cycling through different treatments without achieving their treatment goals. Sarilumab works differently from the most commonly used biologics, such as those in the anti-TNF class, and is a welcome new option for patients and their physicians.”
RA is a chronic inflammatory autoimmune disease, which carries substantial burden. In RA, 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.
“Today’s milestone with Kevzara, which follows closely on the heels of our recent approval of Dupixent (dupilumab), showcases the ability of our internal discovery and science engine to deliver important new medicines by leveraging our leading technologies, such as VelocImmune,” said George D. Yancopoulos, M.D., Ph.D., Founding Scientist, President, and Chief Scientific Officer, Regeneron.