EMA accepts submission of Pfizer’s new arthritis drug

pharmafile | November 21, 2011 | News story | Research and Development, Sales and Marketing | EMA, Pfizer, tofacitinib

The European Medicines Agency has accepted Pfizer’s arthritis drug tofacitinib for review.

Tofacitinib is a novel, oral JAK inhibitor being studied for the treatment of moderate-to-severe active rheumatoid arthritis (RA). The EMA will now assess the drug and will aim to reach a decision next year.

Recent results from the Phase III ORAL study showed that the 10mg twice-daily dose showed statistically significant changes versus placebo in reducing signs and symptoms of RA, but the lower 5mg dose missed its primary endpoint.

If the drug reaches the market it will be competing with a number of established treatments, including Abbott’s Humira, J&J’s Remicade and Pfizer’s own Enbrel, which saw 2010 sales of $6 billion, $4.6 billion and $3.5 billion respectively.

All three are injectable forms of treatments, but whereas tofacitinib is taken as a pill twice-daily, Humira can be injected every other week and patients taking Enbrel must inject themselves twice a week.

J&J’s RA drug Remicade requires administration in hospital every eight weeks.

Ben Adams