The European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of 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. It is developed by therapeutics solutions provider Sanofi and biopharma company Regeneron Pharmaceuticals.
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.
Sarilumab is currently under review in the United States, and the companies are also seeking approvals in a number of other countries globally.
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.
Specifics
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 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 150 mg once every two weeks is recommended for management of neutropenia, thrombocytopenia and liver enzyme elevations.
The CHMP opinion is based on results from seven Phase 3 trials in the global SARIL-RA clinical development programme, 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.
Rheumatoid arthritis
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.
“Rheumatoid arthritis is a painful and debilitating disease which affects millions of people in Europe, many of whom are still struggling to find a treatment that works for them,” said Elias Zerhouni, President of Global R and D at Sanofi.
“Today's positive CHMP opinion for Kevzara brings us one step closer to making this new treatment option available to patients in Europe.”
