Pfizer Inc.'s proposed dose of tofacitinib for the treatment of adult patients with active psoriatic arthritis (PsA) received recommendation for approval by the U.S. Food and Drug Administration’s Arthritis Advisory Committee (AAC) via a 10-1 vote.
The committee provides recommendations to the FDA; the FDA then takes the recommendation into account when deciding whether to approve a drug for U.S. sale and marketing. An FDA decision on whether to approve tofacitinib for PsA should come by December.
“Today marks an important positive step in our journey to potentially bring tofacitinib to adult patients living with active psoriatic arthritis and we are pleased with the committee’s positive recommendation based on the favorable benefit:risk profile for tofacitinib,” Michael Corbo, chief development officer of Inflammation & Immunology at Pfizer Global Product Development, said in a statement. “If approved, tofacitinib would be the first Janus kinase inhibitor for psoriatic arthritis. We look forward to working with the FDA to complete review of the applications.”
PsA is a chronic, autoimmune, inflammatory disease; it usually manifests itself in peripheral joints, tendons, ligaments, bone and skin.