Sanofi and Regeneron receive CHMP positive opinion for rheumatoid arthritis treatment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorisation of Sanofi and Regeneron Pharmaceuticals’ 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.

"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," said Elias Zerhouni MD, President, Global R&D, Sanofi.

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).

Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. The recommended dose of Kevzara is 200 mg once every two weeks administered as a subcutaneous injection.

Final decision

The European Commission (EC) is expected to make a final decision on the marketing authorisation application (MAA) for Kevzara in the European Union in the coming months.

Phase III trials

The CHMP opinion is based on results from seven Phase 3 trials in the global SARIL-RA clinical development program, including SARIL-RA-MOBILITY, SARIL-RA-TARGET and SARIL-RA-MONARCH. 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.

In Europe, 2.9 million people suffer from RA, and living with the disease can make everyday life difficult. Symptoms include joint pain, swelling, stiffness, and fatigue.

Global approval

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.