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Abbott seeks Crohn's indication for Humira

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Published: Sept. 7, 2006 at 10:07 AM

ABBOTT PARK, Ill., Sept. 7 (UPI) -- Abbott said Thursday it filed with U.S. and European regulatory authorities seeking a Crohn's disease use for Humira.

The company filed a supplemental biologics license application with the U.S. Food and Drug Administration and a type 2 variation with the European Medicine Agency for an indication for Humira for the treatment of moderate to severe Crohn's disease.

The filings are based on three trials: CLASSIC I, CHARM, and GAIN.

"Based on our clinical studies, we believe Humira offers promise for patients who suffer from Crohn's disease," said Eugene Sun, Abbott's vice president of global pharmaceutical clinical development.

"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," Sun added.

© 2006 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.

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