ABBOTT PARK, Ill., Nov. 16 /PRNewswire-FirstCall/ -- The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), granted Abbott (NYSE: ABT) a positive opinion recommending approval of HUMIRA(R) (adalimumab) for the treatment of moderate to severe plaque psoriasis. Psoriasis will be the fifth disease indication for HUMIRA.
Psoriasis is a non-contagious, chronic autoimmune disease that causes the body to attack itself. The most obvious physical symptom of the condition is raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. But psoriasis is more than painful skin lesions; data also suggest a correlation between psoriasis and other conditions, including psoriatic arthritis. In addition, psoriasis can seriously affect many aspects of a person's life, from professional and social activities to personal relationships.
"The scales and plaques of psoriasis can cause both physical and emotional distress, making reliable new treatment options essential," said Professor Jean-Hilaire Saurat, M.D., chairman, department of dermatology, University of Geneva, Switzerland. "With almost three quarters of patients in clinical trials achieving 75 percent clearance at sixteen weeks, and almost 20 percent achieving complete clearance, HUMIRA shows tremendous promise for physicians and people living with this condition."
Abbott announced it was seeking E.U. and U.S. regulatory approval for
HUMIRA in psoriasis on April 2, 2007. The European Commission is expected
to issue a decision granting the marketing authorization for HUMIRA as a
treatment for psoriasis in the European Union within the next 60 days.
Abbott is awaiting U.S.
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