Kevzara receives positive CHMP opinion

The European Medicine Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for the marketing authorization of Kevzara, by Regeneron Pharmaceuticals Inc. and Sanofi, in combination with methotrexate for adults with moderate to severely active rheumatoid arthritis who had an inadequate response to or are intolerant to disease-modifying antirheumatic drugs.

"Rheumatoid arthritis is a painful and debilitating disease which impacts millions of people in Europe, many of whom are still struggling to find a treatment that works for them," Elias Zerhouni, MD, President or Global Research and Development at Sanofi, said in a company release. "We welcome today's positive [Committee for Medicinal Products for Human Use] CHMP opinion for Kevzara, which brings us one step closer to making this new treatment option available to patients in Europe."

Elias Zerhouni

According to a company release, Kevzara (sarilumab) — a human monoclonal antibody directed against interleukin-6 — can also be given as monotherapy if the patient is intolerant to methotrexate or if methotrexate use is inappropriate. The recommended dose is a subcutaneous 200 mg injection once every 2 weeks, according to the release. In cases with elevated levels of neutropenia, thrombocytopenia or liver enzymes, the dose should be reduced to 150 mg.

The European Commission will make its final decision on the marketing authorization application of sarilumab in the “coming months,” the release noted. The committee opinion was based on three phase 3 trials, which included 3,300 adults with rheumatoid arthritis who had an inadequate response to a non-biologic disease-modifying antirheumatic drug.

Sarilumab is approved in Canada and is also seeking approval in the United States.

Reference:

http://newsroom.regeneron.com/releasedetail.cfm?releaseid=1022400