Abbott seeks to expand Humira indications

Abbott Laboratories has applied to European and American drug regulatory authorities for the approval of Humira in patients with Crohn’s disease.

Humira, Abbott’s best-selling drug in-licensed from Cambridge Antibody Technology (CAT), is already approved in several countries for use in patients with inflammatory diseases like rheumatoid arthritis or ankylosing spondylitis.

Abbott has submitted data from three clinical trials, which found that a higher proportion Crohn’s disease patients using Humira had achieved clinical remission within two weeks of first taking the drug.

Additionally, the company said it will submit more data from a study of patients with moderate to severe Crohn’s disease who had become resistant to infliximab, the Schering-Plough drug, and had then turned to Humira treatment.

Stephen Hanauer, professor of medicine and clinical pharmacology at the University of Chicago’s section of gastroenterology and nutrition, stated: “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.”

Eugene Sun, vice president of global pharmaceutical clinical development at Abbott added: “Data from three pivotal studies in more than 1,400 patients suggest the potential of Humira to help many Crohn’s disease patients meet their treatment goals of achieving and maintaining control of symptoms and improving quality of life.”

Abbott’s royalty payments to CAT will now be inherited by AstraZeneca after the UK company decided to acquire the antibody research company three months ago.

CAT had previously disputed the size of Abbott’s royalty payments, although the companies settled the issue in October last year before the matter went to court.

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