Sanofi and Regeneron Pharmaceuticals have announced that the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorisation of Kevzara® (sarilumab), recommending its approval for use in adult patients with moderately to severely active rheumatoid arthritis.
“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. “We welcome today’s positive CHMP opinion for Kevzara, which brings us one step closer to making this new treatment option available to patients in Europe.”
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 200mg once every two weeks administered as a subcutaneous injection. Reduction of dose from 200mg once every two weeks to 150mg once every two weeks is recommended for management of neutropenia, thrombocytopenia, and liver enzyme elevations.
The European Commission 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 III 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 3300 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 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.