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Published on 19 November 2007

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EMEA gives green light to Humira

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The European Medicines Agency (EMEA) is recommending approval of Humira (adalimumab) for the treatment of moderate to severe plaque psoriasis.

The manufacturer Abbott announced it was seeking EU and US regulatory approval for the drug to treat the condition on 2 April.

The European Commission is now expected to grant the marketing authorisation for Humira in the European Union in the next two months, which will be the fifth disease indication for the medication.

Abbott is still awaiting Food and Drug Administration (FDA) approval for Humira to treat the skin condition.

Psoriasis is an autoimmune disease that causes the body to attack itself.

The most obvious symptoms are raised, red skin lesions known as plaques, which may crack and bleed.

Professor Jean-Hilaire Saurat, from the department of dermatology at the University of Geneva in Switzerland, said: “The scales and plaques of psoriasis can cause both physical and emotional distress, making reliable new treatment options essential.

“With almost three quarters of patients in clinical trials achieving 75% clearance at 16 weeks, and almost 20% achieving complete clearance, Humira shows tremendous promise for physicians and people living with this condition.”

Copyright © PA Business 2007

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