Abbott's HUMIRA(R) (adalimumab) FDA-Approved For Moderate to Severe Chronic Plaque Psoriasis

Filed in archive FDA Approvals , Psoriasis & Skin Diseases , Treatment on January 20, 2008

The US FDA has recently approved the marketing of Abbott's HUMIRA(R) (adalimumab) as a treatment for adult patients with moderate to severe chronic plaque psoriasis.

Plaque psoriasis is an autoimmune disease characterized by skin lesions that are sometimes painful and itchy.

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. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

The approval is based on two pivotal trials, REVEAL and CHAMPION, showing that nearly 3 in 4 patients achieved 75 percent clearance or better at week 16 of treatment versus placebo. HUMIRA has 10 years of clinical trial experience beginning with rheumatoid arthritis patients.

Plaque psoriasis is the fifth disease indication for HUMIRA: approved for moderate to severe rheumatoid arthritis in 2002, psoriatic arthritis in 2005, ankylosing spondylitis in 2006, and moderate to severe Crohn's disease in 2007.

Find more details from CNN Money.

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