Abbott seeks Humira psoriasis claim
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Abbott submits an sBLA for its tumor necrosis factor inhibitor Humira (adalimumab) for treatment of moderate to severe chronic plaque psoriasis, the company announced April 2. The submission is based on the results of two double-blind, placebo-controlled trials of Humira - REVEAL and CHAMPION - evaluating the biologic based on the Psoriasis Area and Severity Score. The 52-week REVEAL study evaluated more than 1,200 patients with moderate to severe chronic plaque psoriasis, for which 71 percent achieved PASI 75 or better compared to 6.5 percent on placebo. The 16-week CHAMPION study evaluated 271 patients; 80 percent of patients treated with Humira achieved PASI 75 or better compared to 36 percent treated with methotrexate. Humira gained a Crohn's indication Feb. 27, making it the first self-administered biologic approved for Crohn's (1Pharmaceutical Approvals Monthly March 2007, In Brief). The biologic is also approved for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis...