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.
The randomized phase 3b/4 ORAL Surveillance study included 4362 RA patients who were taking methotrexate without adequate control of symptoms.
Patients treated with tofacitinib experienced significantly fewer disease flares compared with placebo.
Safety Alerts and Recalls
The revisions are based on a completed review of a large randomized safety clinical trial, which included 4362 patients with rheumatoid arthritis.
The update follows the FDA’s Drug Safety Communication, which was based on a completed review of a large randomized safety clinical trial evaluating tofacitinib in patients with rheumatoid arthritis.
Drugs in the Pipeline
The applications are supported by data from two 2two phase 3 induction studies and one 1 maintenance study.