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

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Sanofi and Regeneron’s 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.

Sarilumab works by targeting the IL-6 receptor and has been developed for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

The therapy has so far successfully been trialled in seven phase III studies, involving in excess of 3300 adult patients, most of whom had failed to respond to previous treatment regimens.

Sanofi Genzyme, the specialty care global business of Sanofi, will commercialise sarilumab if it is authorised. 

A biologics licence application for sarilumab was also accepted for review by the US Food and Drug Administration during the first quarter of 2016. A decision is expected in the next few months.