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Humira cleared for Crohn’s

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Abbott's tumor necrosis factor inhibitor Humira (adalimumab) gained a Crohn's indication from FDA Feb. 27, and may offer a potential benefit over J&J's Remicade (infliximab) as the first self-administered biologic approved for Crohn's disease. Humira is administered subcutaneously every other week, while Remicade requires an infusion. Previously approved for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, Humira's new indication is for reducing the signs and symptoms and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have an inadequate response to conventional therapy. Abbott expects Humira to generate peak sales of $500 million in the Crohn's disease indication. UCB had hoped to beat Humira to approval with its Crohn's candidate Cimzia, but received a "complete review" letter from FDA in December (1Pharmaceutical Approvals Monthly January 2007, p.19)...

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