Sanofi and Regeneron announce EMA acceptance for review of Marketing Authorisation Application for sarilumab

Sanofi and Regeneron Pharmaceuticals, Inc. have announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) for sarilumab, an investigational human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

The MAA for sarilumab is primarily based on results from seven Phase 3 trials in the global SARIL-RA clinical development programme, including SARIL-RA-MOBILITY, SARIL-RA-TARGET and SARIL-RA-MONARCH. These studies incorporate data from more than 3,300 adults with moderately to severely active RA the majority of who were inadequate responders to previous treatment regimens such as disease-modifying anti-rheumatic drugs (DMARDs) or anti-tumour necrosis factor alpha (anti-TNFα).

The goal of the clinical development programme has been to evaluate the safety and efficacy of sarilumab, either as monotherapy or in combination with conventional DMARDs, including methotrexate (MTX), in reducing the signs and symptoms, improving physical function and inhibiting the radiographic progression of RA. The extension part of the SARIL-RA-MONARCH trial and a long term safety trial called SARIL-RA-EXTEND are ongoing.

A biologics license application (BLA) for sarilumab was accepted for review by the U.S. Food and Drug Administration (FDA) in the first quarter of 2016. Per the Prescription Drug User Fee Act (PDUFA), the target action date is Oct. 30, 2016.

The safety and efficacy of sarilumab have not been fully evaluated by any regulatory authority. If authorised, sarilumab would be commercialised by Regeneron and Sanofi Genzyme, the specialty care global business of Sanofi.