The U.S. Food and Drug Administration (FDA) will review Pfizer’s medication Xeljanz (tofacitinib citrate) 5 mg twice daily, to treat adults with active psoriatic arthritis (PsA) who had an inadequate response to conventional treatments, following the FDA’s approval of a supplemental New Drug Application (sNDA).
The FDA also accepted a separate sNDA for Xeljanz XR extended release 11 mg once-daily use by psoriatic arthritis patients.
The sNDA submission package included data from the OPAL clinical development program which encompassed two Phase 3 studies — OPAL BROADEN (NCT01877668), and OPAL BEYOND (NCT01882439). These studies assessed Xeljanz in adult PsA patients who responded inadequately to treatment with conventional synthetic disease-modifying antirheumatic drugs or to tumor necrosis factor inhibitors. The package Pfizer gave the FDA also included interim results from OPAL BALANCE (NCT01976364), a long-term extension clinical trial of the drug in patients with active PsA.
In December 2016, Pfizer reported that both clinical trials met their primary efficacy endpoints. This means that there were statistically significant improvements with treatment with Xeljanz (5 mg and 10 mg) compared to treatment with placebo. Researchers measured this by the American College of Rheumatology 20 (ACR20) response at three months, and by the change from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI), a self-assessment of disability levels tool.
In both trials, the HAQ-DI scores showed that patients had a statistically significant improvement following treatment with Xeljanz, when compared to treatment with a placebo. Based on the Prescription Drug User Fee Act, the FDA will likely decide on the sNDAs by year’s end.
“Psoriatic arthritis is a complex disease involving joint inflammation and damage, psoriasis, and musculoskeletal inflammation, which may limit physical functioning for people living with the disease,” Pfizer executive Michael Corbo said in a press release. “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.”
Added Corbo, chief development officer of inflammation and immunology in Pfizer’s Global Product Development unit: “We believe that Xeljanz has the potential to provide patients with psoriatic arthritis and their physicians a new treatment option that also offers oral administration. 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.”
Xeljanz, which belongs to a class of drugs known as janus kinase (JAK) inhibitors, has been approved in more than 50 countries for the treatment of patients with a diagnosis of moderate to severe rheumatoid arthritis (RA) as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs.