The approval was based on data from a phase 3 study which evaluated tofacitinib in adults with active AS who had an inadequate response to at least 2 NSAIDs.
For patients with rheumatoid arthritis, a novel oral Janus kinase inhibitor, tofacitinib, is associated with reduced symptoms when used as monotherapy or in addition to background methotrexate.
The addition of tofacitinib to rheumatoid arthritis (RA) treatment regimens improves patient response to non-biologic disease-modifying antirheumatic drugs (DMARDs).
A total of 18.5% patients taking tofacitinib experienced a remission of their condition in 8 weeks compared to just 8.2% of patients receiving placebo.
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.
Safety Alerts and Recalls
The Food and Drug Administration (FDA) has approved changes to the prescribing information for tofacitinib to include new warnings, including a Boxed Warning, regarding an increased risk of blood clots and death associated with the 10mg twice daily regimen. The update comes after a review of data from an ongoing safety clinical trial of tofacitinib…
Tofacitinib is superior for patients with inadequate response to TNF inhibitors or conventional DMARDs
Tofacitinib, an oral inhibitor of Janus kinase 1, 2, and 3, can reduce disease severity and induce remission better than a placebo in patients with moderately to severely active ulcerative colitis.
Drugs in the Pipeline, News
The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.
Drugs in the Pipeline
Pfizer announced results from the OPT (Oral treatment Psoriasis Trial) Retreatment study (A3921111) assessing tofacitinib for the treatment of adults with moderate-to-severe chronic plaque psoriasis.