FDA Advisory Committee recommends tofacitinib for the treatment of adult patients with active psoriatic arthritis. - Pfizer

Pfizer Inc. announced that FDA Arthritis Advisory Committee (AAC) voted 10 to 1 to recommend approval of the proposed dose of tofacitinib for the treatment of adult patients with active psoriatic arthritis. (PsA). Pfizer submitted supplemental new drug applications (sNDAs) for Zeljanz 5 mg twice daily (BID) and Xeljanz XR extended release 11 mg once daily (QD) for this pending indication.

The role of the Advisory Committee is to provide recommendations to the FDA. The FDA decision on whether to approve tofacitinib for PsA is anticipated by December 2017. If approved, tofacitinib would be the first Janus kinase (JAK) inhibitor for psoriatic arthritis.