Pfizer’s Xeljanz Meets Primary Endpoints in Two Phase 3 Trials

Pfizer’s oral Xeljanz sent more patients suffering from moderate to severe ulcerative colitis into remission, meeting primary endpoints in two Phase 3 clinical trials, the company reported last week.

The placebo-controlled studies tracked 1,139 patients over two months and found a twice daily dosage of Xeljanz (tofacitinib) saw increased remission at week 8 compared to placebo.

The hope is that the tablets will make the chronic bowel disease easier to treat in as many as one-third of patients who do not find relief in current therapies. Unlike past trials, there were no safety concerns, nor serious health events as a result of the medication, according to Pfizer.

Xeljanz, a Janus kinase inhibitor, was approved in 2012 as second-line treatment for moderate to severe rheumatoid arthritis for patients who didn’t react well to methotrexate.

The drug’s label carries a black box warning and has been linked to risk of serious infections and some types of cancers due to its role in lowering immune system responses. Some patients have contracted tuberculosis, bacterial and viral infections, lymphomas and skin cancers.

The clinical program for the UC sNDA includes another identical Phase 3 study, which is expected to conclude by winter 2016, and an extension trial. — Victoria Pelham