Statistically significant improvements were shown 3 months vs. placebo with tofacitinib, in this new study
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Tofacitinib 5mg or 10mg twice daily showed a consistent safety profile and sustained efficacy over 5 years in long-term extension studies for patients with rheumatoid arthritis, as presented at the 2013 ACR/ARHP Annual Meeting.
Pfizer announced top-line results from two pivotal Phase 3 trials, evaluating the efficacy and safety of Xeljanz (tofacitinib) for the treatment of moderate-to-severe plaque psoriasis.
Pfizer announced top-line results from the OPAL Beyond study, the second Phase 3 trial of Xeljanz (tofacitinib citrate) for the potential treatment of patients with active psoriatic arthritis (PsA).
According to data from on an ongoing postmarketing safety trial conducted by Pfizer, tofacitinib dosed at 10mg twice daily was associated with an increased risk of pulmonary embolism and overall mortality in patients with rheumatoid arthritis (RA).
The FDA has issued a Complete Response Letter (CRL) for the supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate; Pfizer) for the treatment of adults with moderate to severe chronic plaque psoriasis.
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.
Pfizer announced that the FDA has accepted for review its New Drug Application (NDA) for tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The NDA is based on previously completed Phase 3 trials.
Pfizer announced results from two Phase 3 studies from the Oral treatment Psoriasis Trials (OPT) program for tofacitinib citrate in adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
The expanded FDA approval was based on results from two 8-week placebo-controlled induction trials and a 52-week maintenance study.