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Yesterday a FDA advisory panel voted 15-0 in favor of approving Xeljanz (tofacitinib) 10 mg bid for patients with moderate to severe ulcerative colitis.
The US Food and Drug Administration’s (FDA) convened the Gastrointestinal Drugs Advisory Committee Meeting (GIDAC) to assess Pfizers supplemental new drug application for tofacitinib in adult patients with moderately to severely active ulcerative colitis (UC).
This panel is advisory to the FDA and no decision has yet been made on drug approval; although the FDA usually follows advisory panel recommendations.
Tofacitinib is currently approved for use in rheumatoid arthritis and psoriatic arthritis at a dose of 5 mg bid (or 11 mg once daily). This new recommendation for approval of the 10 mg bid dose would be the first approval of "high dose" Xeljanz. Although higher doses were studied and petitioned for by Pfizer, the FDA has only approved the lower dose noting no substantial efficacy advantage while questioning the safety of the higher dose.
If approved, tofacitinib will be the first JAK inhibitor and the first oral therapy for patients with active ulcerative colitis. It would also be the 2nd approval for tofacitinib within a 6 month period.
The company proposed an initial 8 week regimen of tofacitinib 10 mg BID for induction to be followed by tofacitinib 5 mg BID for maintenance. But the panel voted 8-7 against a post-marketing efficacy study comparing a tofacitinib 10 mg BID continuous dosing regimen versus a regimen of tofacitinib 10 mg BID induction and 5 mg BID maintenance.
A decision on this application is expected by June 2018.