FDA Approves Uceris (Budesonide) for Patients With Active Ulcerative Colitis
Launch scheduled for March 2013 (Jan. 14)
The FDA has approved Uceris (budesonide, Santarus, Inc.) extended-release tablets for the induction of remission in patients with active, mild-to-moderate ulcerative colitis. The commercial launch is expected in March 2013.
Uceris contains budesonide, a corticosteroid, in an oral tablet formulation. The approved dosing regimen for adult patients is one 9-mg tablet taken once daily in the morning for up to 8 weeks.
Ulcerative colitis is a form of chronic inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon, which can interfere with the colon’s normal function. The disease typically starts to manifest in patients as young adults. Ulcerative colitis is an intermittent disease with periods of exacerbated symptoms, or flares, and periods that are relatively symptom-free. Active ulcerative colitis is often characterized by cramping, bloating, diarrhea, bleeding, fatigue, weight loss, and frequent bowel movements. Although the symptoms of ulcerative colitis may resolve without treatment, the disease usually requires medication to go into remission. According to the Crohn's and Colitis Foundation of America, 700,000 people in the U.S. have ulcerative colitis.
A new drug application (NDA) for Uceris was submitted to the FDA in December 2011.
The drug was evaluated for the treatment of patients with mild or moderate active ulcerative colitis in two phase III clinical trials — one conducted in the U.S. and India, and the other conducted in the E.U. In these studies, Uceris 9 mg once daily met the primary endpoint of superiority versus placebo (P = 0.0143 in the U.S. study and P = 0.0047 in the E.U. study) in achieving clinical remission, as measured by the Ulcerative Colitis Disease Activity Index (UCDAI) score after 8 weeks of treatment.