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news.Abbott has received FDA approval to market Humira as a treatment for adult patients with moderate to severe chronic plaque psoriasis, an autoimmune disease characterized by skin lesions that are sometimes painful and itchy.
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Humira has been approved for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. The company said that Humira should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
Abbott said that the approval of Humira is based on data from more than 1,400 adult patients in two pivotal trials, REVEAL (randomized controlled evaluation of adalimumab every other week dosing in moderate to severe psoriasis trial) and CHAMPION (comparative study of Humira vs. methotrexate vs. placebo in psoriasis patients). Both studies evaluated the efficacy and safety of Humira in clearing skin in moderate to severe adult plaque psoriasis patients versus placebo.