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FDA approves Enbrel to treat psoriasis

ling disease requiring continuous treatment. ENBREL was shown to provide rapid and significant relief of psoriasis in many patients," said Alice Gottlieb, M.D., Ph.D., director of the Clinical Research Center at the University of Medicine and Dentistry of the New Jersey-Robert Wood Johnson Medical School. "Additionally, in one clinical trial, patients who stopped treatment did so without experiencing disease flare or rebound. The trial also demonstrated, that upon retreatment with ENBREL the overall response rates were similar to those seen after initial treatment."

ENBREL was generally well tolerated in both Phase 3 studies. Adverse events were similar to those reported in previous clinical trials in other indications. The most common adverse events in the ENBREL group when compared to placebo were injection site reactions.

ABOUT PSORIASIS

An estimated 4.5 million people in the United States suffer from psoriasis and 1.5 million have moderate to severe plaque psoriasis. The disease is characterized by chronic inflammation of the skin. This inflammation helps drive the formation of red, itchy skin plaques that are often painful and disfiguring. Tumor necrosis factor (TNF) is found at increased levels in psoriatic plaques and plays a critical role in their formation and continued existence.

ABOUT ENBREL

ENBREL is the only fully human TNF receptor approved to reduce signs and symptoms, improve physical function, and inhibit the progression of structural damage in patients with moderately to severely active rheumatoid arthritis (RA), and to reduce the signs and symptoms and inhibit the progression of structural damage of active arthritis in patients with psoriatic arthritis. ENBREL is the only biologic therapy approved for first-line treatment of RA patients, and can be used alone or in combination with methotrexate. It is approved to reduce the signs and symptoms of moderately to severely active polyarticu
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2-May-2004


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