Here are six things to know.
1. The committee was not specifically asked to vote if tofacitinib should be approved for ulcerative colitis, an indication that drug manufacturer Pfizer seeks.
2. Tofacitinib is currently approved to treat rheumatoid and psoriatic arthritis in a dosing regimen of five milligrams twice a day.
3. According to Pfizer chief development officer Michael Corbo, tofacitinib will be the first Janus kinase inhibitor and first oral therapy for adults with moderately to severely active ulcerative colitis.
4. The GIDAC voted on two dosing questions related to the use of the 10 milligrams twice-daily dose beyond the eight week induction period. The GIDAC first voted unanimously (15-zero) in favor of extending the dose from eight to 16 weeks of induction in adult patients who have not achieved adequate benefit by week eight.
5. The committee also voted unanimously in favor of the dose as continuous maintenance treatment for adults with an inadequate response, loss of response or intolerance to tumor necrosis factor blocker therapy. The unanimous vote came despite some committee members’ concerns about infections, especially the possibility of herpes zoster developing with the higher dose. According to MedPage Today, they noted this is a “desperate population,” and the benefits appeared greater than the risks.
6. While the FDA is not bound to follow the recommendations of its advisory committees, it often does. The FDA’s decision on whether or not to approve tofacitinib for ulcerative colitis is expected by the Prescription Drug User Fee Act date in June 2018.
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