Abbott seeks Crohn’s disease indication for Humira

Clinical trials have been completed evaluating the efficacy and safety of Humira in a range of moderate-to-severe Crohn's disease patients. In these trials, Humira demonstrated statistical significance in inducing and maintaining clinical remission in patients with the disease. As a result of the study some of the patients involved who were able to maintain remission, were also able to discontinue steroid use.

Crohn's disease is a serious, chronic inflammatory disease of the gastrointestinal tract that affects more than one million people in North America and Europe combined. Currently, there is no cure for Crohn's disease, reinforcing the need for safe and effective treatment options that will help patients maintain control of their disease.

“Humira may offer much-needed hope to physicians, as well as to people living with Crohn's disease, who have had limited, effective, long-term treatment options,” said Stephen Hanauer, Professor of Medicine, Section of Gastroenterology and Nutrition, University of Chicago.

Humira is Abbott's best selling drug and is already a treatment for rheumatoid and psoriatic arthritis. Humira is also the only fully human antibody approved by the FDA. Clinical trials are currently under way evaluating the potential of Humira in other immune-mediated diseases.