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FDA to evaluate Humira as potential treatment for ulcerative colitis

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An FDA advisory committee will meet Aug. 28 to recommend whether approval for Abbott Laboratories’ Humira should be expanded to include use in patients with ulcerative colitis.

If approved, Humira (adalimumab) would be administered for reducing symptoms and inducing remission of moderate-to-severe ulcerative colitis in adult patients who have been unresponsive to standard treatment. The proposed dosage, to be introduced via subcutaneous injection, consists of four 40-mg injections on the first day or two 40-mg doses on the first and second day, followed by 80 mg after 2 weeks and a biweekly 40-mg maintenance dose.

According to FDA briefing documents, Abbott will present data from three trials, including a single-arm, open-label study and two randomized, double blind, placebo-controlled trials, as evidence of the product’s safety and efficacy for this indication.

Topics to be reviewed will include appropriate dosage and treatment population, evidence for efficacy, risk-benefit analysis and whether additional pre- or post-approval studies are necessary.

Humira is approved to treat inflammatory conditions including Crohn’s disease and rheumatoid arthritis.