Approval of tofacitinib (Xeljanz) for ulcerative colitis has been recommended by a unanimous vote of the FDA’s Gastrointestinal Drugs Advisory Committee.
The JAK inhibitor is the first in its class to be recommended for adults living with moderately to severely active ulcerative colitis.
The committee voted 15-0 in favour of the extension of the use of tofacitinib 10 mg twice a day from eight to 16 weeks of induction in adult patients who have not achieved adequate therapeutic benefit by Week 8.
It also voted unanimously in favour of 10 mg twice a daily as continuous maintenance treatment for adult patients with an inadequate response, loss of response or intolerance to TNF blocker therapy.
The recommended ulcerative colitis (UC) indication was based on the OCTAVE trials, including a phase 2 study, two identical phase 3 induction trials and a phase 3 maintenance trial and open-label extension study.
The committee rejected by a 7-8 vote a recommendation that the drug’s manufacturer Pfizer conduct a post-marketing efficacy trial comparing a 10-mg continuous dosing regimen with a 10-mg induction and 5 mg twice daily as maintenance.