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Abbott's HUMIRA(R) (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis
Date:1/18/2008

tis and arthralgia. HUMIRA is self-administered as an injection. Patients are treated with an initial 80 mg dose of HUMIRA (two 40 mg injections) followed by one HUMIRA injection (40 mg) one week later. After that, a maintenance dose of 40 mg is administered every other week.

"HUMIRA has demonstrated its versatility in effectively treating multiple autoimmune diseases, and this approval expands the therapeutic resources available to dermatologists and other physicians who take care of patients with psoriasis and psoriatic arthritis," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott.

In April 2007, Abbott simultaneously submitted a supplemental Biologics License Application (sBLA) with the FDA and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA (adalimumab) as a treatment for chronic plaque psoriasis. EMEA approval was received in December 2007, and the U.S. approval makes psoriasis the fifth autoimmune disease indication for HUMIRA.

More Information on Psoriasis

While psoriasis can occur in people of all ages, it typically appears in patients between the ages of 15 and 35, and currently has no cure. In a recent survey from the National Psoriasis Foundation, nearly 40 percent of psoriasis respondents reported feelings of helplessness and self-consciousness as a result of their disease.

Psoriasis varies from person to person and treatment depends largely on type, location, severity, age and medical history, and the primary treatment goals are to reduce the thickness, redness, scaling and itching of the skin. Treatment may include topical agents, phototherapy or medication taken by pill or injection.

Important Safety Information

Serious infections, sepsis, tuberculosis (TB) and opportunistic infections, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA.

Many of these serious infection
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SOURCE Abbott
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