European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Sanofi’s and Regeneron Pharmaceuticals’s product Kevzara (sarilumab), recommending its approval for use in adult patients with moderately to severely active rheumatoid arthritis.
Kevzara is an investigational human monoclonal antibody directed against the IL-6 receptor. The CHMP recommended the use of Kevzara in combination with methotrexate (MTX) for the treatment of moderately to severely active RA in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs), the companies said.
The European Commission (EC) is expected to make a final decision on the Marketing Authorization Application (MAA) for Kevzara in the European Union in the coming months. The CHMP opinion is based on results from seven Phase 3 trials in the global SARIL-RA clinical development program.
In Canada, Kevzara is approved for use in adult patients with moderately to severely active RA who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs. Sarilumab is currently under review in the United States, and the companies are also seeking approvals in a number of other countries globally, the companies said.