Pfizer just announced that the FDA agreed to review a daily, 11-milligram modified-release tablet of its rheumatoid arthritis drug Xeljanz for patients who don't respond adequately to methotrexate (marketed as Rheumatrex and Trexall). The candidate's PDUFA date, by which acceptance (or rejection) of the New Drug Application (NDA) is supposed to occur, is February 2016.
Xeljanz is currently offered as a twice-daily 5-mg tablet. The NDA is based on data designed to show that the 11-mg version is equivalent to that dosage form. The FDA is also reviewing 10-mg and 5-mg dosages of the tablet to treat moderate to severe chronic plaque psoriasis among adults who are candidates for systemic therapy or phototherapy, Pfizer ($PFE) says.
Xeljanz inhibits the Janus kinase family of enzymes, and its benefit/risk profile for rheumatoid arthritis sufferers has been studied on about 6,200 patients globally, Pfizer says. It is approved for use in 40 countries.
"This filing underscores our commitment to helping advance patient care and our goal of providing innovative solutions for patients with RA," said Dr. Rory O'Connor, Pfizer's head of Global Medical Affairs, in a statement. "If approved, it would bring us one step closer to offering the first and only once-daily oral Janus kinase inhibitor treatment for those living with moderate to severe RA who have had an inadequate response or intolerance to methotrexate."
Xeljanz had revenues of $308 million in 2014, up from $114 million in 2013. That's partly because Pfizer spent $160.7 million in advertising expenditure on the drug last year. Still, its performance has fallen short of peak sales expectations of as high as $3 billion per year.
- read the release
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