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Gail M. ZimmermanPresident and CEONational Psoriasis FoundationPortland, Ore.www.psoriasis.org Testimony to the FDA Dermatologic and Ophthalmic Drugs Advisory Committee May 23, 2002
National Psoriasis Foundation Our mission is to improve the quality of life of people who have psoriasis and psoriatic arthritis. Through education and advocacy, we promote awareness and understanding, ensure access to treatment and support research that will lead to effective management and, ultimately, a cure.
Financial disclosure information: FY2001 and FY2002 Corporate members in general support of the NPF’s mission: Abgenix Connetics Genentech MedImmune Allergan Corixa ICN Novartis Alva-Amco Daavlin ISIS Protein Design Labs Biogen Fujisawa Immunex Corp./Wyeth Centocor Galderma Medicis Roche Unrestricted educational grants in support of programs and services: Allergan Fujisawa ICN Roche Biogen Genentech Immunex Corp./Wyeth Bristol-Myers Squibb Protein Design Labs Schering
Physically disabling and emotionally devastating Moderate to severe psoriasis
Sleep Covering up with clothes – shame, embarrassment Hours of treatment a day Work Children Relationships Suicide “Psoriasis rarely kills people, but it is murder to live with” Moderate to severe psoriasis significantly impacts the most common, intimate aspects of day-to-day life:
People with psoriasis need new options • There are 1.5 million people in this country with moderate to severe psoriasis • New medications will have unknown risks, but the list of KNOWN long-term risks of currently available therapies includes liver and kidney toxicities and birth defects
Moderate to severe psoriasis • Long-term, all existing medications for moderate to severe psoriasis are seriously limited by either efficacy or toxicity • 33 percent are very unsatisfied with today’s available treatments • 78 percent are not using available therapies (phototherapy or systemic medications), primarily due to side effects and lack of effectiveness
Moderate to severe psoriasis • These 1.5 million people will likely require DECADES of treatment for their psoriasis • What are their options?
Risk/benefit considerations What we know vs. what we don’t know • Existing systemic treatments for psoriasis have serious known long-term risks, or are limited in efficacy • Many patients and physicians are willing to accept unknown long-term risks of biologic therapy
NPF position: approve Amevive • Psoriasis severely affects quality of life • People with psoriasis need and deserve adequate treatment options to clear or improve their disease • Access to new treatment options like Amevive is needed