Sanofi and Regeneron receives CHMP backing for rheumatoid arthritis drug

Sanofi and Regeneron have received a recommendation for EU approval of Kevzara as a new treatment for rheumatoid arthritis.

The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorisation of Kevzara, 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, and is designed for use in combination with methotrexate, or as a monotherapy when the use of methotrexate is unsuitable.

Data from seven phase III trials in the global SARIL-RA clinical development programme have highlighted the safety and efficacy of the drug among more than 3,300 adult patients who have are unable to benefit from treatment with disease-modifying antirheumatic drugs.

Dr Elias Zerhouni, president for global research and development at Sanofi, said: "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."

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