Abbott announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), granted a positive opinion recommending approval of HUMIRA? (adalimumab) for the treatment of severe Crohn’s disease.
HUMIRA will be the first self-administered biologic for the treatment of Crohn?s disease. This is an important milestone for Abbott, as Crohn’s disease will be the fourth approved indication for HUMIRA.
Crohn’s disease is a serious, chronic, inflammatory disease of the gastrointestinal (GI) tract that affects more than 1 million people in Europe and North America. There is no medical or surgical cure for Crohn’s disease and there are few treatment options for patients suffering with this chronic condition. Crohn’s affects people of all ages but it is primarily a disease of adolescents and young adults, with onset typically between the ages of 15 and 40.
“HUMIRA will fill an important unmet need in Crohn’s, a condition where we’ve had few effective treatment options, by offering sustained remission from disease and improved quality of life,” said Jean-Fr?d?ric Colombel, M.D., professor of Gastroenterology, H?pital Huriez, France. HUMIRA has been shown to be effective even in patients who have failed other therapies.
The European Commission is expected to issue a decision granting the marketing authorization for HUMIRA as a treatment of Crohn’s disease in the European U nion within the next 60 days. In February 2007, HUMIRA was approved under priority review by the U.S. Food and Drug Administration for the treatment of moderately to severely active Crohn’s disease.
The positive opinion is based on results of three randomized, double-blind, placebo-controlled, multi-center trials of HUMIRA. In each trial, clinical remission was measured by a Crohn’s Disease Activity Index (CDAI) score of less than 150. CDAI is a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, levels of general well being and other measures.