Abbott Receives Positive Opinion for HUMIRA in Ulcerative Colitis from EMA's CHMP
Positive Opinion Based on Supporting Data from Two Phase III Clinical Studies
Abbott announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for HUMIRA® (adalimumab) 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 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 approximately 25 percent of UC patients will undergo some type of surgery to treat their symptoms during their lifetimes.
"A diagnosis of ulcerative colitis can be devastating - it can disrupt a patient's life and cause pain, bleeding and hospitalization," said John Leonard, M.D., senior vice president, Pharmaceuticals Research and Development, Abbott. "Today's positive opinion is a step forward in making HUMIRA available to patients with UC throughout the European Union and underscores our long-standing commitment to patients with IBD."
The positive opinion for HUMIRA for the UC indication was based on two Phase III clinical trials which evaluated clinical remission with HUMIRA in adult patients with moderate to severe UC. HUMIRA will be indicated for the treatment of moderately to severely active ulcerative colitis 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.
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