Regeneron Pharmaceuticals Inc. and its French pharmaceutical partner Sanofi announced that the European Commission has authorized the companies’ antibody drug sarilumab – trademarked as Kevzara – to treat adult patients with moderately to severely active rheumatoid under certain conditions.
Kevzara can be used in combination with methotrexate to treat those patients who have responded inadequately to or who are intolerant of one or more disease-modifying anti-rheumatic drugs. Kevzara may be used as sole treatment in cases of intolerance to methotrexate or when treatment with methotrexate is inappropriate.
A fully human monoclonal antibody, Kevzara was developed using Westchester-based Regeneron’s proprietary VelocImmune technology.
In persons with rheumatoid arthritis, the immune system attacks the tissues of the joints, causing inflammation, joint pain, swelling, stiffness, fatigue and eventually joint damage and disability. It affects approximately 2.9 million people in Europe alone, according to Regeneron and Sanofi, and is most common in persons ages 35 through 50.
“RA is a difficult-to-treat, lifelong disease and many health care providers are challenged with finding a treatment that works for their patients,” said Elias Zerhouni, president of global research and development at Sanofi. “Kevzara works differently from some of the other most commonly used biologics and its approval is good news for the many patients where a high unmet need remains.”
The European Commission’s approval was based upon an evaluation of results from seven Phase 3 trials of the drug, administered to more than 3,300 adult rheumatoid arthritis patients in Sanofi’s and Regeneron’s global clinical development program, by the European Medicine Agency’s Committee for Medicinal Products for Human Use.
The U.S. Food and Drug Administration in May also approved sarilumab, which is given to rheumatoid arthritis patients by subcutaneous injection every two weeks. The drug is also approved in Canada and Regeneron and Sanofi said they are seeking approvals in a number of other countries.