Pfizer announces EMA acceptance of regulatory submission for Tofacitinib for the treatment of Rheumatoid Arthritis

Pfizer Inc. (NYSE:PFE) announced today that its Market Authorisation Application for tofacitinib (development code CP-690,550), a novel, oral JAK inhibitor being studied for the treatment of moderate-to-severe active rheumatoid arthritis (RA), has been validated by the European Medicines Agency (EMA). Validation means that the EMA has confirmed that the application is complete and the agency is beginning its review procedure.

Pfizer studied tofacitinib for moderate-to-severe active RA in the Phase 3 ORAL (Oral Rheumatoid Arthritis Phase 3 TriaLs) program. The ORAL Trials program consists of five studies for which data needed for registration are complete and one ongoing Phase 3 clinical trial. In addition, tofacitinib is being investigated in two ongoing long-term open-label extension studies. Close to 5,000 RA patients at more than 350 sites in 35 countries worldwide have been treated with tofacitinib in clinical trials.