US regulators have agreed to review Pfizer’s application to market a once-daily formulation of its JAK-inhibitor Xeljanz for the second-line treatment of rheumatoid arthritis.
The US Food and Drug Administration will consider whether the new daily version is safe and effective for the treatment of RA patients who are intolerant or unresponsive to treatment with the standard of care methotrexate.
In 2012 Xeljanz (tofacitinib) won approval with twice-daily oral dosing as the first JAK-inhibitor for RA patients and the first new new oral disease-modifying anti-rheumatic drug (DMARD) for the condition in more than 10 years.
A decision by the FDA on the once-daily formulation is expected in February next year. The regulator is also currently assessing Xeljanz for adults with moderate to severe chronic plaque psoriasis, a decision on which is expected by October this year.