FDA Advisory Panel Recommends 10mg Xeljanz Dosing Regimen

A Gastrointestinal Drugs Advisory Committee panel voted unanimously in favor of including a 16-week induction dosing regimen of 10mg Xeljanz (tofacitinib) twice daily in patients who have not reached “adequate therapeutic benefit” by Week 8 on the product label.

“I definitely think there’s better benefit than risk,” said panel member and gastroenterology expert Lin Chang, a professor of medicine at the David Geffen School of Medicine at UCLA.

The 15-member panel also voted unanimously in favor of including the same dosing regimen for adult patients with moderately to severely active ulcerative colitis who have shown inadequate response, loss of response or intolerance to TNF blocker therapy.

The FDA’s representatives said the agency found the 10mg dose was likely to result in better clinical efficacy compared to the 5mg dose.