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FDA Backs Approval of Abbott's Humira for New Use

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08/28/2012 | 10:06pm CEST

WASHINGTON--A federal advisory panel backed the use of an Abbott Laboratories (>> Abbott Laboratories) drug, Humira, as a treatment for patients with inflammatory bowel disease, saying many patients would benefit from treatment with the product.

Abbott is seeking expanded approval from the U.S. Food and Drug Administration for its anti-inflammatory drug Humira to treat ulcerative colitis. Humira, which had almost $8 billion in annual sales last year, currently is approved to treat rheumatoid arthritis, Crohn's Disease and other inflammatory conditions.

The drug was reviewed Tuesday by the FDA's gastrointestinal drugs advisory committee, which is made up of non-FDA medical experts. The panel voted 15 to 2 on a question that asked whether "the expected benefits outweigh the known and potential risks of Humira" for the treatment of certain patients with ulcerative colitis.

The vote amounts to a recommendation that the FDA approve the product. The FDA usually follows the advice of its panels but is not required to. The FDA declined to approve Humira for colitis last year and asked the company for additional information. The agency also said it would seek the advice of an advisory panel.

Abbott studied Humira in two clinical trials involving more than 1,000 patients. Both studies met goals showing Humira improved rates of disease remission compared to a placebo in people with colitis, an inflammatory bowel disease that causes pain, diarrhea and other symptoms. Patients in the studies also were being treated with older commonly used drugs for colitis including steroids.

Although the FDA agreed that the studies met their goals, the agency questioned whether the difference in remission rates of less than 10% between the Humira groups and placebo groups was "clinically meaningful." The studies showed about 17% to 19% of patients being treated with Humira achieved disease remission at eight weeks compared to about 9% of patients being treated with a placebo, according to the FDA. After one year of treatment the results were similar.

"The central issue is whether the applicant has adequately demonstrated and provided evidence of benefit sufficient to conclude that the benefit outweighs the risks of Humira for [ulcerative colitis]," the FDA said in a background memo prepared for the advisory committee meeting.

However, the majority of the panel disagreed, voting 15 to 1 saying that the differences between the drug and placebo groups were clinically meaningful.

Abbott officials and doctors who spoke on behalf of the company during the panel meeting said many patients with colitis don't respond well to currently available treatments, which also include Johnson & Johnson's (>> Johnson & Johnson) Remicade, and need an additional option. The company proposed stopping treatment in patients who don't respond to the drug after eight weeks of treatment.

Write to Jennifer Corbett Dooren at [email protected]

(CORRECTION: This item was corrected to show that the vote tally was 15 to 2. The original incorrectly stated 12 to 2 in the third paragraph.)

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

Stocks mentioned in the article : Abbott Laboratories, Johnson & Johnson
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