US regulatory advisors are backing use of Pfizer’s JAK inhibitor Xeljanz to treat adults with moderately to severely active ulcerative colitis (UC).
The US Food and Drug Administration’s Gastrointestinal Drugs Advisory Committee voted unanimously (15-0) in favour of marketing clearance for the drug in this setting.
The decision came after clinical trials showed that after eights weeks’ treatment, a significantly greater proportion of patients receiving tofacitinib were in remission compared to those taking a placebo - 18.5 percent versus 8.2 percent in the OCTAVE Induction 1 trial and 16.6 percent vs 3.6 percent in OCTAVE Induction 2.
The two trials also showed that a significantly greater number of patients in the tofacitinib arm achieved the secondary endpoint of mucosal healing at week eight compared to placebo: 31.3 percent versus 15.6 percent and 28.4 percent compared to 11.6 percent, respectively.
“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,” said Michael Corbo, chief development officer, Inflammation & Immunology, Pfizer Global Product Development, commenting on the decision.
Xeljanz is already on the market for treating rheumatoid arthritis and psoriatic arthritis, generating sales of around $1.35 billion last year.