FDA Advisory Panel recommends Humira (Abbott Labs) for treatment of Ulcerative Colitis - 30-Aug-2012
The FDA Gastrointestinal Drugs Advisory Panel voted 15-2 to recommend Humira (adalimumab) from Abbott Labs for reducing the signs and symptoms of moderate to severe Ulcerative Colitis in patients who have an inadequate response to conventional therapy.The members of the Panel considered that the benefits outweight the potential risks with the drug. The Panel called for post-approval studies in Ulcerative Colitis to determine whether a higher dose than that proposed in the application might be tested to confirm the optimal dose.
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