EMA accepts MMA for rheumatoid arthritis treatment Sarilumab

pharmafile | August 1, 2016 | News story | Research and Development, Sales and Marketing EMA, MAA, Regeneron, Sanofi, sarilumab 

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

The MMA is based on results garnered from seven Phase III trials, incorporating data from more than 3.300 participants suffering from the disease, the majority of which did not respond adequately to previous treatments such as disease-modifying anti-rheumatic drugs (DMARDs) or anti-tumour necrosis factor alpha (anti-TNFα).

The US Food and Drug Administration (FDA) accepted a biologics license application for the drug in the Q1 2016. The target action date is 30 October, in line with the Prescription Drug User Fee Act (PDUFA).

Matt Fellows

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