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news.Pfizer's Market Authorisation Application for tofacitinib, an oral JAK inhibitor used to treat active rheumatoid arthritis (RA), has secured validation by the European Medicines Agency (EMA).
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The move implies that EMA has confirmed the completion of the application and will begin the review procedure.
Tofacitinib has been studied in the Phase 3 ORAL (Oral Rheumatoid Arthritis Phase 3 TriaLs) program for the treatment of moderate-to-severe active RA.
The drug candidate is also being assessed in two ongoing long-term open-label extension studies.