Abbott Seeks US, European OK To Sell Humira For Crohn's

Abbott Laboratories Inc. (ABT) said early Thursday that it's filed with U.S. and European regulators seeking approval to sell its drug Humira for the treatment of moderate to severe Crohn's disease, a serious and chronic intestinal inflammatory disorder. Drug Pipeline

Abbott said evidence from three pivotal studies suggests Humira can help hold back Crohn's disease symptoms for long periods.

Humira, which posted $1.4 billion in global sales in 2005, is currently approved to treat three types of arthritis, including rheumatoid arthritis. Abbott has projected global Humira sales of more than $1.9 billion this year.

In a release, the Abbott Park, Ill., company said it filed simultaneous applications with the U.S. Food and Drug Administration and the European Medicines Agency. The company didn't estimate when it might achieve approval or bring the product to market.

In the U.S., a standard FDA review could run for up to ten months. If the agency decides to grant Humira a "priority review," a designation for drugs that could fulfill an unmet need, the review time could be reduced to six months.

It is estimate that as many as 1 million Americans have inflammatory bowel disease, half of them with Crohn's disease, according to the Crohn's and Colitis Foundation of America, a nonprofit group that raises money for research. Abbott said Crohn's disease affects more than 1 million people in North America and Europe combined, and that the current market for Crohn's treatment is about $1.1 billion, half of that amount met by biologic therapy.

Abbott said the market could grow to more than $1.8 billion over the next eight to 10 years, based on company and outside estimates.

Crohn's disease does not have a cure. The disorder most often affects the end of the small intestine and beginning of the large intestine, and can lead to complications including intestinal obstruction. According to the nonprofit foundation, two-thirds to three-quarters of patients with Crohn's disease will require surgery at some point in their lives, with surgery becoming necessary when medications, like anti-inflammatory drugs or steroids, can no longer control symptoms.

In multiple trials to evaluate Humira's capability as a treatment for mild-to-severe Crohn's disease, the drug "demonstrated statistical significance in inducing and maintaining clinical remission in patients" with the disorder, Abbott said. In a study evaluating Humira's ability to maintain remission, a proportion of patients in clinical remission were able to stop steroid use, Abbott said.

The drug is self-injected by patients on an every-other-week basis.