Sarilumab regulatory filing accepted by EMA

The European Medicines Agency has accepted for review the Marketing Authorization Application for sarilumab, an investigational human monoclonal antibody directed against the interleukin (IL)-6 receptor that is intended for the treatment of adult patients with moderately-to-severely active rheumatoid arthritis (RA).

The drug is being developed by French pharma major Sanofi (Euronext: SAN) and US partner Regeneron Pharmaceuticals (Nasdaq: REGN), which have previously predicted that the drug could be a blockbuster with sales in excess of $1 billion a year. The Evaluate group has forecast that 2020 sales will hit $1.8 billion.

The MAA for sarilumab is primarily based on results from seven Phase III trials in the global SARIL-RA clinical development program, 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-tumor necrosis factor alpha (anti-TNFα). The monotherapy SARIL-RA-MONARCH study met its primary endpoint by demonstrating that sarilumab was superior to adalimumab, AbbVie’s mega blockbuster drug Humira, in improving signs and symptoms in patients with active rheumatoid arthritis (RA).