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.
Psoriasis is an incurable, recurring disease of the immune system that can first strike at any age, causing dry, painful skin lesions that itch, crack and bleed. Psoriasis often also causes arthritic symptoms (known as psoriatic arthritis).
Psoriasis is not contagious, although the emotional scars it often leaves can also negatively impact a patient’s loved ones.
Psoriasis is common, with as many as 7.5 million Americans affected, according to the U.S. National Institutes of Health.