Pfizer has announced that its Marketing Authorisation Application for tofacitinib, a novel, oral JAK inhibitor being studied for the treatment of moderate-to-severe active rheumatoid arthritis (RA), has been accepted for review by the European Medicines Agency.

The drug has been evaluated in the phase III ORAL (Oral Rheumatoid Arthritis Phase III TriaLs) programme, which 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.