EU recommendation for Sanofi and Regeneron's arthritis treatment

Sanofi and Regeneron are celebrating the news that their treatment Kevzara (sarilumab) has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use for the treatment of moderately to severely active rheumatoid arthritis in adult patients.

The investigational monoclonal antibody, which works by targeting the IL-6 receptor, has been recommended for use in combination with methotrexate (MTX) in patients who have proven non-responsive to disease-modifying anti-rheumatic drugs (DMARDs). The decision was based on the findings of seven Phase 3 trials examining 3,300 participants.

The European Commission will now take this recommendation into account when it decides whether to approve the drug on the continent within months.  

"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, President, Global R&D at 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 treatment is already approved in Canada and is under review in the US.