FDAnews
www.fdanews.com/articles/102516-ec-approves-new-indication-for-humira

EC Approves New Indication for Humira

December 21, 2007

Abbott has received marketing authorization from the European Commission (EC) for Humira as a treatment for moderate to severe plaque psoriasis.

In two trials, approximately half of the patients taking Humira (adalimumab) achieved 90 percent clearance 16 weeks into treatment.

Eugene Sun, Abbott’s vice president of Global Pharmaceutical Clinical Development, said patients taking the drug maintained skin clearance for up to a year.

Psoriasis is the fifth approved indication for Humira in the European Union. The FDA is reviewing an application for the drug for this indication.