EU approves Kevzara (sarilumab) in combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis- Sanofi and Regeneron Pharmaceuticals

Sanofi and Regeneron Pharmaceuticals announced that the European Commission 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.

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), which evaluated results from seven Phase III trials in the global SARIL-RA clinical development program. These studies incorporate data from more than 3,300 adults with moderately to severely active RA who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs.

The program includes the Phase III MONARCH study, in which treatment with Kevzara 200 mg monotherapy was superior to adalimumab 40 mg (marketed by AbbVie as HUMIRA) monotherapy in reducing disease activity and improving physical function, with more patients achieving clinical remission over 24 weeks.