14 December 2017 - Xeljanz/Xeljanz XR, the first oral JAK inhibitor in the U.S.for adults with moderate to severe rheumatoid arthritis, is now approved for adults with active psoriatic arthritis.

Pfizer announced today that the United States FDA has approved Xeljanz 5 mg twice daily and Xeljanz XR (tofacitinib) extended release 11 mg once daily for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying anti-rheumatic drugs. Xeljanz/Xeljanz XR is the first and only Janus kinase inhibitor approved by the FDA for both moderate to severe rheumatoid arthritis and active PsA.

The FDA approval of Xeljanz for the treatment of adult patients with active PsA was based on data from the Phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program, which consisted of two pivotal studies, OPAL Broaden and OPAL Beyond, as well as available data from an ongoing long-term extension trial, OPAL Balance.

Read Pfizer press release