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FDAnews Drug Daily Bulletin
Aug. 30, 2012 | Vol. 9 No. 171
Citing Unmet Need, FDA Advisers Urge Approval of Abbott’s Humira for Ulcerative Colitis
Despite “fragile” trial data, the FDA should approve Abbott Laboratories’ proposed new indication for its blockbuster Humira to treat ulcerative colitis (UC) because new therapies for the chronic condition are needed and clinicians are comfortable with the drug’s safety profile, agency advisers say. More studies are needed to clarify lingering safety and dosing concerns raised by the data, but they should take place after approval, the FDA’s Gastrointestinal Drugs Advisory Committee said Tuesday.
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