Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the European Commission (EC) has granted marketing authorization for Kevzara® (sarilumab) in combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to – or who are intolerant to – one or more disease modifying anti-rheumatic drugs (DMARDs), such as MTX.Kevzara may be used as monotherapy in case of intolerance to MTX or when treatment with methotrexate is inappropriate.
Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) and blocks pro-inflammatory IL-6 mediated signaling. Elevated levels of IL-6 are found in the synovial fluid of patients with RA and play an important role in both the pathologic inflammation and joint destruction which are hallmarks of RA.
“RA is a difficult-to-treat, lifelong disease and many healthcare providers are challenged with finding a treatment that works for their patients,” said Elias Zerhouni, M.D., President, Global R&D, Sanofi. “Kevzara works differently than some of the other most commonly used biologics, and its approval is good news for the many patients with a high unmet need.”
RA affects approximately 2.9 million people in Europe alone. In RA, the immune system attacks the tissues of the joints, causing inflammation, joint pain, swelling, stiffness, fatigue, and eventually joint damage and disability. RA is most common in those aged 35-50 years old.
“We are pleased to bring Kevzara to European patients who may not be responding to the most commonly used biologics such as TNF inhibitors, or who may be seeking an effective monotherapy to reach their treatment goals,” said George D. Yancopoulos, M.D., Ph.D., Founding Scientist, President, and Chief Scientific Officer, Regeneron. “This approval was made possible through the hard work of our innovative scientists, as well as thousands of dedicated investigators and patients around the world who participated in the SARIL-RA clinical trial program.”
The EC approval is based upon receipt of a positive opinion by European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Kevzara is also approved in the United States and Canada.