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FDA Accepts Review of Supplemental New Drug Applications of Xeljanz, Xeljanz XR for Psoriatic Arthritis
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The FDA has accepted to review the supplemental new drug applications of Xeljanz at 5 mg twice daily, as well as Xeljanz XR extended release at 11 mg once daily, both for the treatment of patients with psoriatic arthritis, according to a company press release.
“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,” Chief Development Officer, Inflammation & Immunology, Global Product Development at Pfizer, Michael Corbo, said in the 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.”
The submissions used data from two phase 3 trials and a long-term extension study of Xeljanz (tofacitinib, Pfizer) in patients with active psoriatic arthritis who failed prior treatment. The first phase 3 trial was done in patients with an inadequate response to conventional disease-modifying antirheumatic drugs and who had yet to take tumor necrosis factor inhibitors (TNFis). In addition, the study included an active control arm of patients who took adalimumab (Humira, AbbVie); although, the study did not record non-inferiority or superiority comparisons between adalimumab and tofacitinib. The second phase 3 trial was done in patients with an inadequate response to TNFis and focused exclusively on patients with psoriatic arthritis. Both studies reportedly met their endpoints and showed 3-month improvements in both ACR20 and Health Assessment Questionnaire Disability Index for tofacitinib at 5-mg and 10-mg twice daily doses compared with placebo. However, in both studies, the adverse event rate was greater for tofacitinib than the placebo group; although, the release noted this was still consistent with the safety profile for tofacitinib overall, which includes patients with rheumatoid arthritis, an indication for which tofacitinib is FDA-approved.
According to the release, the FDA anticipates the Prescription Drug User Fee Act action date to be December 2017.
“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,” Corbo said. “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.”
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