NPF says FDA approval of new psoriasis drug signals new era of care

January 31, 2003

PORTLAND, Ore., Jan. 31, 2003 - The National Psoriasis Foundation issued a statement today in support of the Food and Drug Administration's (FDA) approval of the first biologic drug to treat psoriasis. The FDA has approved Biogen's alefacept (brand name Amevive) to treat moderate to severe psoriasis.

"The Food and Drug Administration's approval of Amevive, is a significant step forward for the psoriasis community," said Gail Zimmerman, president and CEO of the National Psoriasis Foundation. "This drug represents the emergence of a new class of treatment that represents the most significant advance in psoriasis care in 20 years."

While there are multiple treatments available for the more than 4.5 million adults with psoriasis in the United States, many people have not been able to find satisfactory relief and are in urgent need of additional treatment options, added Zimmerman. Today's psoriasis treatments--some of which were developed to treat other diseases--don't work equally well for everyone, experts at the Psoriasis Foundation agree. In addition, some also have the potential for side effects, which limits their use.

According to a recent survey conducted by the Psoriasis Foundation, 75 percent of people with moderate to severe psoriasis said that their psoriasis is a large problem in their life. Seventy-eight percent of those surveyed say they don't use more aggressive therapies to treat their disease because of side effects and lack of effectiveness.

"Amevive was designed to block and eliminate cells involved in psoriasis. Its effects have provided long-term therapeutic results for many patients. More importantly, at this point the drug is not associated with any significant adverse events," said Gerald Krueger, M.D., a professor of dermatology at the University of Utah School of Medicine and chairman of the Psoriasis Foundation's Medical Advisory Board.

As a new class of treatment for people with psoriasis and psoriatic arthritis, biologic therapy offers new options for dermatologists and patients. Biologics are a class of drugs engineered from proteins produced by living cells. In treating psoriasis, biologics disrupt the immune-system processes that drive the disease. They have caused few side effects in short-term studies, but long-term safety for psoriasis patients is yet unknown.

While Amevive is the first biologic drug available for psoriasis, many others are in development, including Genentech's efalizumab (brand name Raptiva), which was recently submitted to the FDA for approval. Amgen's etanercept (brand name Enbrel), has already been approved to treat psoriatic arthritis and recent study results indicate that it is also effective in treating psoriasis. Amgen expects to conclude a second phase III trial of Enbrel this year. If the results are satisfactory, Amgen may file for approval of Enbrel for treating psoriasis by the end of 2003.

"Each time a pharmaceutical or biotech company moves forward with a new treatment for psoriasis and psoriatic arthritis, we feel new hope for those who suffer from these diseases because we know they may soon receive greater relief and improved quality of life," Zimmerman added.

The National Psoriasis Foundation encourages people with psoriasis who want to improve their treatment or learn about additional options to talk with their dermatologist or health care provider.
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About Psoriasis
Psoriasis is a chronic disease that is driven by the immune system and typically first strikes people between the ages of 15 and 35. Psoriasis occurs when faulty signals in the immune system cause skin cells to regenerate too quickly -- every three to four days instead of the usual 30-day cycle. Extra skin cells build up on the skin's surface, forming red, flaky, scaly patches called plaques that can itch, crack, bleed and are often times extremely painful. Psoriasis generally appears on the joints, limbs and scalp, but it can appear anywhere on the body, covering some people from head to toe.

About the National Psoriasis Foundation
The National Psoriasis Foundation is the leading nonprofit organization fighting to improve the quality of life of people with psoriasis and psoriatic arthritis and their families. It receives its principal support from public donations. Its mission is to educate people about these diseases and their treatments, raise public awareness, and support ongoing research. The organization is headquartered in Portland, Ore., and serves the millions of men, women, and children diagnosed with psoriasis and psoriatic arthritis. For more information, please call the Psoriasis Foundation at (800) 723-9166 or visit www.psoriasis.org.

National Psoriasis Foundation

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