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Title: FDA Approves Biologic Drug, Enbrel (Etanercept), for Psoriasis

"FDA Approves Biologic Drug, Enbrel (Etanercept), for Psoriasis"

PORTLAND, OR -- May 3, 2004 -- The U.S. Food and Drug Administration (FDA) approved the biologic drug etanercept (brand name Enbrel) to treat chronic, moderate to severe plaque psoriasis in adults. The drug, marketed by Amgen and Wyeth Pharmaceuticals, is already approved to treat psoriatic arthritis. The National Psoriasis Foundation hailed the news as continuing a historic new era for psoriasis patients. "Managing psoriasis is a lifelong battle, and patients frequently tell us they need additional treatment options," said Gail Zimmerman, president and CEO of the Psoriasis Foundation. "The last 18 months have brought several new choices for patients, and with Enbrel, we now have a drug approved for both psoriasis and psoriatic arthritis. This is an exciting time for psoriasis patients and their families." Psoriasis is an incurable skin disease that occurs when faulty signals in the immune system cause skin cells to regenerate too quickly, resulting in inflamed, scaly lesions that can itch, crack, bleed and be extremely painful. Psoriatic arthritis is a degenerative disease of the joints and connective tissues associated with psoriasis. About 1.5 million Americans have moderate to severe psoriasis, and an estimated one million Americans have psoriatic arthritis. "I have had great success with Enbrel," said Sally Housley, a Psoriasis Foundation member from Rio Rancho, New Mexico who has taken Enbrel for more than a year as part of a psoriasis clinical trial. "Psoriasis can be devastating, but Enbrel has done wonders for me. I feel like a totally new person, both physically and emotionally." Enbrel's approval for psoriasis continues the advance of biologics, a series of new drugs engineered from proteins produced by living cells. Early last year, Biogen's Amevive (alefacept) became the first biologic drug approved for psoriasis, while Genentech's Raptiva (efalizumab) was approved for psoriasis last fall. Centocor's Remicade (infliximab) and Abbott Laboratories' Humira (adalimumab) are in clinical trials for both psoriasis and psoriatic arthritis, and other biologics are in the development pipeline. Biologics have caused few side effects in short-term studies, but long-term safety for psoriasis patients is not yet known. Oral tazarotene, a non- biologic retinoid manufactured by Allergan, is also pending before the FDA for moderate to severe psoriasis. Psoriasis is a difficult disease to treat, in part because some treatments work well for some patients but do not work for others. This makes it particularly important for patients to have several treatment choices available. "Etanercept targets a specific protein that produces an inflammatory response in both psoriasis and psoriatic arthritis," said Craig Leonardi, M.D., Clinical Associate Professor of Dermatology at Saint Louis University and a member of the Psoriasis Foundation's Medical Board. "Throughout the trials, patients had impressive, safe and consistent responses to etanercept therapy. Having an established record in treating psoriatic arthritis, etanercept is now the first of the new biologic drugs able to treat the full spectrum of psoriatic disease. There is no doubt that this drug will be well received by psoriasis sufferers and the dermatologists who treat them." About Psoriasis Psoriasis generally appears on the joints, limbs and scalp but it can appear anywhere on the body, covering some people from head to toe. More than 5 million Americans have been diagnosed with psoriasis and/or psoriatic arthritis. Psoriasis typically first strikes people between the ages of 15 and 35, but can affect anyone at any age, including children. SOURCE: National Psoriasis Foundation

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