Tofacitinib (Pfizer) is filed at EMA for Rheumatoid Arthritis

A market authorisation application for tofacitinib (CP-690,550),a novel, oral JAK inhibitor from Pfizer has been validated by the European Medicines Agency (EMA) for for the treatment of moderate-to-severe active Rheumatoid Arthritis. Validation means that the EMA has confirmed that the application is complete and the agency is beginning its review procedure. The application is supported by the results of Phase III ORAL trials programme. The ORAL Trials programme consists of five studies for which data needed for registration are complete and one ongoing Phase III clinical trial. In addition, tofacitinib is being investigated in two ongoing long-term open-label extension studies.