The Food and Drug Administration (FDA) has accepted for review two separate supplemental New Drug Applications (sNDA) for Xeljanz (tofacitinib citrate; Pfizer) and Xeljanz XR (tofacitinib citrate extended-release) for the treatment of psoriatic arthritis.
The submission was based on two Phase 3 studies: OPAL Broaden and OPAL Beyond. OPAL Broaden was conducted in conventional synthetic disease-modifying antirheumatic drug inadequate response (IR) and tumor necrosis factor inhibitor (TNFi)-naïve patient populations.
OPAL Beyond was conducted in TNFi-IR patients and was the first PsA study focused exclusively in this population. Both studies met their primary efficacy endpoints showing a statistically significant improvement with tofacitinib compared to placebo at three months as measured by American College of Rheumatology 20 (ACR20) response and change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score.
“Despite advances in the treatment of psoriatic arthritis in recent years, many people are still living with active disease and are in need of additional therapeutic options,” said Michael Corbo, of Global Product Development at Pfizer. “If approved, Xeljanz or once-daily Xeljanz XR would be the first and only Janus kinase inhibitor for the treatment of this chronic inflammatory disease.”
A long-term extension study, OPAL ‘Balance’ is currently ongoing though the company has included interim results in the new sNDAs.
An anticipated Prescription Drug User Fee Act (PDUFA) action date of December 2017 has been set by the FDA for both sNDAs.
For more information visit Pfizer.com.