Posted by Michael Wonder on 27 Jun 2017
Sanofi and Regeneron announce approval of Kevzara (sarilumab) to treat adult patients with moderately to severely active rheumatoid arthritis in the European Unio
27 June 2017 - Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the European Commission has granted marketing authorisation for Kevzara (sarilumab) in combination with methotrexate for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have responded inadequately to – or who are intolerant to – one or more disease modifying anti-rheumatic drugs, such as methotrexate.
Kevzara may be used as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.
The European Commission approval is based upon receipt of a positive opinion by EMA's CHMP, which evaluated results from seven Phase 3 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.
