FDA approves Uceris (Santarus) for mild to moderate Ulcerative Colitis

The FDA has approved Uceris (budesonide) extended release tablets, from Santarus, for the induction of remission in patients with active, mild to moderate Ulcerative Colitis. Approval is based on two trials, namely study CB 01-02/02 in Europe and CB 01-02/01 in USA and India, which showed the drug superior to placebo in achieving clinical remission as measured by the Ulcerative Colitis Disease Activity Score after 8 weeks of treatment.

Specifically, Uceris is indicated for use in the induction of remission of active disease, an acute phase of the disease often characterized by cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements. The company expects to commence the commercial launch of Uceris in March 2013.