FDA Advisory Committee Backs Pending Approval of Xeljanz to Treat Psoriatic Arthritis


If approved, Xeljanz will be the first Janus kinase inhibitor for psoriatic arthritis.

The FDA’s Arthritis Advisory Committee voted 10 to 1 yesterday in favor of tofacitinib citrate (Xeljanz) to treat adult patients with active psoriatic arthritis (PsA).

Pfizer Inc submitted a supplemental New Drug Application (sNDA) for 5 mg of tofacitinib citrate twice-daily and 11 mg once daily of Xeljanz XR extended release. The decision on whether to approve tofacitinib for PsA is expected by December 2017.

Tofacitinib citrate is a Janus kinase inhibitor. It is currently approved to treat patients with moderate-to-active rheumatoid arthritis who did not respond to methotrexate or other non-biologic disease-modifying antirheumatic drugs.

“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 developmental officer of Inflammation & Immunology at Pfizer Global Product Development, said in a press release. “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.”

The committee discussions were based on data in the sNDA from the tofacitinib phase 3 trial in PsA, and additional safety analyses form the broader tofacitinib clinical development program.

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