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Home Industry News Sanofi and Regeneron’s new rheumatoid arthritis drug accepted for EU review

Sanofi and Regeneron’s new rheumatoid arthritis drug accepted for EU review

9th August 2016

Sanofi and Regeneron has announced that their new rheumatoid arthritis therapy sarilumab has been accepted for European regulatory review.

The European Medicines Agency has accepted the companies' marketing authorisation application for the investigational human monoclonal antibody, which works by targeting the IL-6 receptor.

It has been developed for the treatment of adult patients with moderately to severely active rheumatoid arthritis and has been successfully trialled in seven phase III studies, assessing the drug among more than 3,300 adults.

The majority of these patients were inadequate responders to previous treatment regimens, such as disease-modifying antirheumatic drugs and anti-TNFs, suggesting sarilumab could be effective in treating those for whom current therapy options have failed.

A biologics licence application for sarilumab was also accepted for review by the US Food and Drug Administration during the first quarter of 2016, with decisions on whether or not to approve the drug expected in the coming months.

If authorised, sarilumab would be commercialised by Regeneron and Sanofi Genzyme, the specialty care global business of Sanofi.

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