Pfizer says that its JAK inhibitor Xeljanz has hit goals in a late-stage trial assessing its safety and effectiveness in patients with moderate to severe ulcerative colitis.
Two Phase III induction trials with Xeljanz (tofacitinib) 10mg twice daily met their primary endpoints, in showing that significantly more patients taking the drug were in remission at eight weeks than those taking a placebo.
Safety signals also looked promising, with no unexpected observations in either trial. Serious adverse events were similar to those seen in other clinical development programs for the drug, Pfizer noted.
Results of the study, which are to be presented at a future medical conference, will form part of the company’s potential application to market Xeljanz for UC, in addition to data from maintenance trials, results of which are expected next year.
Xeljanz is the first JAK inhibitor being assessed for UC, a chronic, often debilitating inflammatory bowel disease that affects millions of people worldwide. The drug is also the first and only JAK inhibitor approved in over 40 countries for the second-line treatment of moderate to severe rheumatoid arthritis.