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10/05/2009 - News

FDA Approves New Drug for Psoriasis

By: June Chen, MD


The U.S. Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in adults. Plaque psoriasis is the most common type of psoriasis, a chronic skin disorder characterized by red skin covered with silvery scales that can itch or burn.

Stelara is a laboratory-produced human monoclonal antibody that blocks the action of immune substances that contribute to the overproduction of skin cells and inflammation associated with psoriasis. Stelara is administered by subcutaneous injection, and it provides an alternative treatment option for people with plaque psoriasis, which can cause significant physical and psychological discomfort.
The approval of Stelara is supported by data from the ACCEPT trial, a phase III trial involving 903 patients with plaque psoriasis. In ACCEPT, two subcutaneous injections of Stelara administered four weeks apart were more effective for achieving a 75 percent or greater reduction in psoriasis at week 12 than twice-weekly injections of etanercept administered for 12 weeks. 
Stelara may decrease immune response and increase the risk for serious viral, fungal, or bacterial infections, as well as cancer. So, patients with plaque psoriasis should carefully discuss the risks and benefits of Stelara prior to initiating this psoriasis treatment.


Media-Newswire Press Release, released September 28, 2009.

Created on: 10/05/2009
Reviewed on: 10/05/2009

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