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The latest news releases from the National Psoriasis Foundation on research developments into psoriasis and psoriatic arthritis, National Psoriasis Foundation events for its members and the public and other relevant happenings.
National Psoriasis Foundation chairman and volunteers to testify before FDA in support of new psoriasis drug
Approval of the biologic efalizumab (Raptiva) would give millions of psoriasis patients new hope
Portland, Ore., Sept. 9, 2003�The chairman of the National Psoriasis Foundation and two of its volunteer members will testify today before the U.S. Food and Drug Administration (FDA) near Washington, D.C., in support of the drug efalizumab (brand name Raptiva) for the treatment of moderate to severe psoriasis, an immune-mediated chronic skin disease that leads to inflamed, scaly and often painful lesions that can cover part or all of a person's body.
The drug, manufactured by Genentech and XOMA, is a "biologic" therapy that targets a specific part of the immune system involved in psoriasis. Biologic drugs such as Raptiva are a new class of engineered proteins produced by living cells and have been creating a buzz among psoriasis patients, as they offer relief from psoriasis symptoms and appear to be safer than some current treatments.
"Psoriasis has severely impacted my life," said Leslie Holsinger, Ph.D., a psoriasis patient for more than 15 years and chairman of the National Psoriasis Foundation Board of Trustees. "By sharing my story, I hope the FDA will better understand the urgency felt in the psoriasis community for more treatment options."
Raptiva is a humanized antibody that blocks the activation of T cells and migration of those cells into the skin. T cells are a type of white blood cell in the body that normally help us ward off foreign invaders and fight infection. In psoriasis, however, these T cells are mistakenly activated and trigger other immune responses that fuel the development of psoriasis lesions. Raptiva is given by weekly subcutaneous (under the skin) self-injection.
"My quality of life improved dramatically after I entered a Raptiva clinical trial," said Mark Lemelin, a Psoriasis Foundation member from Broomfield, Colo., who will testify today. "This is the most successful treatment I have tried in my 26 years as a psoriasis patient, and it gives me hope for the future."
The hearing will be conducted by the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC), an independent committee of experts that reviews and evaluates available data on drug safety and effectiveness and makes recommendations to the FDA. The FDA generally follows a DODAC recommendation, but is not required to do so.
"Biologics are an exciting development for the psoriasis community," said Gail Zimmerman, president and CEO of the Psoriasis Foundation. "We are asking the FDA to approve Raptiva to provide the more than one and a half million Americans with moderate to severe psoriasis an additional choice as they seek effective control of this incurable disease."
About Psoriasis
Psoriasis is a lifelong skin disease that 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 lesions that can itch, crack, bleed and be 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. More than 5 million Americans have been diagnosed with psoriasis and/or psoriatic arthritis, a degenerative disease of the joints and connective tissues associated with psoriasis. Psoriasis typically first strikes people between the ages of 15 and 35, but can affect anyone at any age, including children.
About the National Psoriasis Foundation
The National Psoriasis Foundation is the leading nonprofit organization fighting to improve the quality of life of the more than 5 million Americans diagnosed with psoriasis and/or psoriatic arthritis and their families. Sustained by annual contributions from nearly 50,000 members as well as corporate and foundation grants, 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. For more information, please call the Psoriasis Foundation at 800.723.9166 or visit http://www.psoriasis.org.
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