The supplemental New Drug Applications (sNDAs) contained data from Phase 3 trials involving patients with psoriatic arthritis, including safety analyses from the larger tofacitinib clinical development program.
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Xeljanz and Xeljanz XR are Janus kinase (JAK) inhibitors indicated to treat moderately to severely active rheumatoid arthritis when methotrexate therapy is inadequate.
Statistically significant improvements were shown 3 months vs. placebo with tofacitinib, in this new study
The GIDAC recommendations are provided to the FDA but they are not binding. The FDA has set a target PDUFA action date of June 2018.
Tocilizumab is known to raise LDL cholesterol levels but it is unclear whether the drug raises CV risk in RA patients.
The analysis focused on comparing the benefits and risks of biologic monotherapy, non-TNF agents, or tofacitinib monotherapy vs. placebo or methotrexate/other DMARDs.
Researchers from the University of Calgary found moderate to high quality evidence that triple therapy with methotrexate + sulfasalazine + hydroxycholoroquine or combining methotrexate + most biologic disease-modifying antirheumatic drug (DMARDs) or tofacitinib demonstrated similar efficacy in controlling disease activity in methotrexate-naive patients or after an inadequate response to methotrexate.
Vaccination rates in patients with rheumatoid arthritis remain poor “despite the high rates of infectious disease-related morbidity and mortality,” a review published in Clinical Opinion in Rheumatology has found.
Pfizer announced that the Food and Drug Administration (FDA) has approved Xeljanz XR (tofacitinib citrate) extended-release tablets for once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX).
The FDA has approved a supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib; Pfizer) to eliminate the requirement for the approved Risk Evaluation and Mitigation Strategy (REMS) assessment.