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news.Abbott has reported that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, granted a positive opinion recommending approval of Humira for the treatment of moderate to severe plaque psoriasis. Psoriasis will be the fifth disease indication for Humira.
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The opinion is primarily based on the results of Reveal and Champion, the two randomized, controlled, multi-center clinical trials in adult patients. In both trials, the signs and symptoms of psoriasis were measured and evaluated using the psoriasis area and severity Index (PASI) among other measures. In Reveal, a pivotal 52-week short-term and sustained clinical efficacy trial, Humira achieved PASI 75 (75% or better improvement in PASI), compared to 6.5% of patients receiving placebo.
In Champion, a pivotal 16-week study evaluating 271 psoriasis patients from eight European countries and Canada, Humira-treated patients experienced a significant reduction, with more than twice the percentage (80%) of patients treated with Humira achieving a PASI 75 response compared to patients treated with methotrexate (36%), a standard systemic treatment for psoriasis, and more than four times the percentage of patients treated with placebo (19%).
The European Commission is expected to issue a decision granting the marketing authorization for Humira as a treatment for psoriasis in the EU within the next 60 days. Abbott is also awaiting FDA approval for this indication.