FDA approves Kevzara for the treatment of moderately to severely active RA in adults

Kevzara is now available to US patients.

Sanofi and Regeneron Pharmaceuticals have announced the FDA approval of 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). 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. 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 RA by reducing signs and symptoms, improving physical function, and resulting in significantly less radiographic progression of structural damage of RA," said Alan Kivitz, CPI, Founder and Medical Director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center, and an investigator in the global SARIL-RA clinical program for sarilumab. "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."

"Despite the many advances made in the treatment of RA, patients continue to need new treatment options," said Olivier Brandicourt, Chief Executive Officer, Sanofi. "Today's approval in the US 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."

"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. "This milestone would not have been possible without our important ongoing collaboration with Sanofi, and most importantly, the patients and physicians who participated in our SARIL-RA clinical program, and worked with us to make Kevzara available to those in the U.S. RA community in need of new options."