Pfizer Inc. said the U.S. Food and Drug Administration approved Xeljanz to treat certain patients with active psoriatic arthritis.
Psoriatic arthritis is a chronic, autoimmune, inflammatory disease that may include manifestations in peripheral joints, tendons, ligaments or skin. It may include a variety of symptoms such as joint pain and stiffness, swollen toes and/or fingers and reduced range of motion.
The FDA approved Xeljanz 5 milligrams twice daily and Xeljanz extended release 11 mg once daily for adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs.
The approval is based on the phase 3 OPAL clinical development program, which consisted of two studies. The studies showed that 50% of patients taking the 5 mg dose of the drug saw an improvement of at least 20% in their disease symptoms.
Xeljanz, or tofacitinib, is already approved to treat adult patients with moderate to severe active rheumatoid arthritis. Pfizer is also seeking approval for Xeljanz to treat adult patients with moderately to severely active ulcerative colitis, an inflammatory bowel disease that causes long-lasting inflammation and ulcers in the digestive tract.