Pfizer’s new rheumatoid arthritis drug accepted for EU review

Pfizer's promising new rheumatoid arthritis drug tofacitinib has been accepted for clinical review by the European Medicines Agency (EMA).

The company's submission for marketing authorisation for the novel oral JAK inhibitor has been validated by the EU body, which will now begin its review procedure.

Tofacitinib is intended for use among patients with moderate to severe cases of rheumatoid arthritis and has been evaluated by Pfizer during an extensive phase III trial programme called Oral.

It consisted of five separate studies to generate data necessary for the EMA review process, while one additional phase III trial and two long-term open-label extension studies remain ongoing.

Almost 5,000 patients have been treated with tofacitinib during the study programme to date, based at more than 350 sites in 35 countries.

Earlier this month, positive data for the drug was presented by the company to attendees of the American College of Rheumatology annual scientific meeting in Chicago.