The European Medicines Agency has approved adalimumab (Humira) for use in the UK for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. This approval marks the seventh indication for adalimumab in the European Union since the product’s first approval in 2003. UC is a chronic infammatory bowel disease that causes ulcers in the colon and may lead to lifethreatening complications. It is estimated that UC afects up to 120,000 people in the UK with between 6,000 and 12,000 new cases diagnosed each year. The approval was based on two Phase III clinical trials (ULTRA 1 and ULTRA 2) involving more than 800 patients across North America, Europe, Australia, New Zealand and Israel.