Sanofi and Regeneron have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the marketing authorisation of Kevzara (sarilumab). The treatment is recommended for use in patients with moderately to severely active rheumatoid arthritis (RA).
Rheumatoid arthritis
Kevzara is an investigational human monoclonal antibody that targets the IL-6 receptor. It has been recommended for use in combination with methotrexate (MTX) in those patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). It can also be administered as a monotherapy in cases of MTX intolerance or where treatment with MTX is inappropriate.
“RA 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 Dr Elias Zerhouni, 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 in Europe.”
The recommended dose of Kevzara is 200 mg once every two weeks administered as a subcutaneous injection. For the management of neutropaenia, thrombocytopaenia and liver enzyme elevations the recommended dose is reduced from 200 mg to 150 mg once every two weeks.
Final decision on marketing authorisation is expected to be made by the European Commission in the coming months.
Sanofi develops and distributes therapeutic solutions and Regeneron is a biopharmaceutical company that discovers, invents, develops, manufactures and commercialises medicines for the treatment of serious medical conditions.