Pfizer eyes gastro use for Xeljanz after thumbs-up from FDA advisers
Pfizer has been steadily building a franchise around its inflammatory diseases pill, Xeljanz (tofacitinib) over the last few years, and it could add another use after US experts recommended a licence in ulcerative colitis.
The FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) has recommended the new use for Xeljanz in adults with moderately to severely active ulcerative colitis.
The FDA usually follows the advice of its expert committees and is due to make a decision before June.
If approved, Xeljanz could offer an oral alternative to injected disease-modifying drugs such as Merck & Co’s Remicade (infliximab), AbbVie’s Humira (adalimumab), and Johnson & Johnson ‘s Simponi (golimumab).
Pfizer has also asked European regulators to extend the drug’s use to include ulcerative colitis.
The GIDAC voted on two dosing questions related to the use of the 10 mg twice-daily (BID) dose beyond the eight-week induction period.
The committee voted unanimously (15-0) in favour of the extension of the use of tofacitinib 10 mg BID from eight to 16 weeks of induction in adult patients who have not achieved adequate therapeutic benefit by week eight.
It also voted unanimously in favour of 10 mg BID as continuous maintenance treatment for adult patients with an inadequate response, loss of response or intolerance to tumour necrosis factor (TNF) blocker therapy.
The GIDAC voted 8-7 against a post-marketing efficacy study comparing a 10mg BID continuous dosing regimen of Xeljanz versus a regimen of 10mg BID induction and 5mg BID as maintenance in this population.
A janus kinase (JAK) inhibitor class drug, Xeljanz has been FDA-approved since 2012 for rheumatoid arthritis as a twice-daily pill, and since 2016 in a daily formulation.
The FDA approved a new indication in psoriatic arthritis at the end of last year.
Michael Corbo, chief development officer, inflammation and immunology, at Pfizer Global Product Development, said: “If approved, tofacitinib will be the first Janus kinase inhibitor and the first oral therapy for adults living with moderately to severely active ulcerative colitis. We look forward to working with the FDA as it completes the review of our pending application.”
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