Abbott Seeks U.S., European Approval for Humira in Psoriasis

Abbott announced it has submitted a supplemental biologics license application to the FDA and a Type II variation to the European Medicines Agency seeking approval to market Humira as a treatment for moderate to severe chronic plaque psoriasis.

The submissions are based on the results of two double-blind, placebo-controlled trials of Humira (adalimumab) -- REVEAL and CHAMPION. In both trials, reduction in disease activity was determined by the Psoriasis Area and Severity Index (PASI) score.

In REVEAL, a pivotal 52-week trial, the short-term and sustained clinical efficacy and safety of Humira were evaluated in more than 1,200 patients with moderate to severe chronic plaque psoriasis. Nearly 71 percent of patients receiving Humira achieved a PASI score of 75 or better, compared with only 6.5 percent of patients receiving placebo. Twenty percent of patients receiving Humira achieved a PASI score of 100 (complete clearance), compared to less than 1 percent of patients receiving placebo.

In CHAMPION, a 16-week study evaluating 271 psoriasis patients from eight European countries and Canada, twice the percentage of patients treated with Humira achieved PASI 75 compared with patients treated with methotrexate. Nearly 17 percent of patients treated with Humira achieved PASI 100 at week 16, compared with 7 percent of patients receiving methotrexate and 2 percent of patients receiving placebo.

Humira, a fumor necrosis factor blocker, is currently approved to treat moderate to severe rheumatoid arthritis, psoriatic arthritis and moderate to severe Crohn's disease.