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FDA accepts to review Pfizer’s sNDA for XELJANZ to treat adult PsA patients

Published 04 May 2017

The US Food and Drug Administration (FDA) has accepted for review Pfizer's supplemental New Drug Application (sNDA) for XELJANZ (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA).

A separate sNDA was also accepted for XELJANZ XR (tofacitinib citrate) extended release 11 mg once daily use in PsA. The sNDA submission is based on data from the Phase 3 Oral Psoriatic Arthritis TriaLs (OPAL) clinical development program, which consisted of two pivotal trials and a long-term extension study, evaluating the safety and efficacy of XELJANZ in patients with active PsA who had failed prior PsA treatments.

The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in December 2017 for the sNDAs.

Michael Corbo, Chief Development Officer, Inflammation & Immunology, Global Product Development, said: “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. 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.

“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.”

Two pivotal Phase 3 studies were included in the submission package. OPAL Broaden was conducted in conventional synthetic disease-modifying antirheumatic drug (csDMARD) inadequate response (IR) and tumor necrosis factor inhibitor (TNFi)-naïve patient populations.

The study included an active control arm of adalimumab. However, the study was not designed for non-inferiority or superiority comparisons between adalimumab and XELJANZ.

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 XELJANZ 5 mg and 10 mg BID compared to treatment with 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.

In both studies adverse events were more frequent with XELJANZ 5 mg and 10 mg BID versus placebo. Overall safety findings were consistent with those observed in the broader rheumatology clinical development program for XELJANZ. Interim results from OPAL Balance, the long-term extension study of XELJANZ in patients with active PsA, were also included in the submission package.

Source: Company Press Release