FDA approval for Kevzara in rheumatoid arthritis

The US Food and Drug Administration has approved 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).

Developed by France’s Sanofi (Euronext: SAN) and USA-based Regeneron Pharmaceuticals (Nasdaq: REGN), 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.

Regeneron’s shares gained 2.44% to $460.99 by close of trading on Monday, and moved up to $464.50 in after-hours trading, while Sanofi edged up around 0.4% in early activity today. Kevzara is already approved in Canada and last month received a positive re commendation from the European regulator. Last fall, the companies received a Complete Response Letter from the FDA delaying Kevzara’s approval.