EMA advisory backs Humira for UC and expanded use of Byetta

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Friday issued a positive opinion for US health care major Abbott Laboratories’ (NYSE: ABT) blockbuster rheumatoid and psoriatic arthritis drug Humira (adalimumab), for use in adults with moderate to severely active ulcerative colitis (UC) who have not responded to, cannot tolerate or have medical contraindications to conventional therapies.

Based on the CHMP's positive opinion, a final decision from the European Commission is anticipated in the next few weeks. Upon final decision, Humira – which generated sales of $9.93 billion for Abbott in 2011 - will be the first and only self-injectable biologic therapy available for moderate to severe UC patients.

UC is a chronic inflammatory bowel disease that causes inflammation in the colon and may lead to life-threatening complications. There is no known cure for UC other than surgical removal of the colon. It is estimated that UC affects up to 1.2 million people in the European Union and around 25% of UC patients will undergo some type of surgery to treat their symptoms during their lifetimes.