FDA wants more research before considering Pfizer RA drug Xeljanz for use in psoriasis
On October 14, 2015, Pfizer announced that the US Food and Drug Administration (FDA) has declined to approve Pfizer’s rheumatoid arthritis drug Xeljanz (tofacitinib citrate) to treat moderate to severe plaque psoriasis in adult patients.
The FDA, in what is called a Complete Response Letter, made recommendations to Pfizer about what additional information it should provide to try again to win approval of Xeljanz for psoriasis.
Xeljanz is a promising new treatment that comes in a pill form, rather than via injection or infusion. For rheumatoid arthritis, Zeljanz is taken as one pill, twice a day. It is for adults with moderate to severe RA for whom methotrexate didn’t work well. But the drug has raised safety concerns that have slowed its rate of adoption by patients and physicians. The company is also investigating the drug for ulcerative colitis.
Pfizer announced it remains committed to working with the FDA to secure approval of Xeljanz for plaque psoriasis.
We’ll keep you posted.