Gail M. Zimmerman President and CEO National Psoriasis Foundation Portland, Ore. www.psoriasis.org Testimony to the FDA Dermatologic and Ophthalmic Drugs.

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Presentation transcript:

Gail M. Zimmerman President and CEO National Psoriasis Foundation Portland, Ore. 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.

Corporate members in general support of the NPF’s mission: Abgenix ConneticsGenentechMedImmune AllerganCorixa ICNNovartis Alva-AmcoDaavlin ISISProtein Design Labs Biogen Fujisawa Immunex Corp./Wyeth CentocorGalderma Medicis Roche Unrestricted educational grants in support of programs and services: Allergan Fujisawa ICNRoche Biogen Genentech Immunex Corp./Wyeth Bristol-Myers Squibb Protein Design Labs Schering Financial disclosure information: FY2001 and FY2002

Physically disabling and emotionally devastating Moderate to severe psoriasis

Moderate to severe psoriasis significantly impacts the most common, intimate aspects of day-to-day life: 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”

People with psoriasis need new options 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 There are 1.5 million people in this country with moderate to severe psoriasis

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 Long-term, all existing medications for moderate to severe psoriasis are seriously limited by either efficacy or toxicity

These 1.5 million people will likely require DECADES of treatment for their psoriasis Moderate to severe 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