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Exelon rivastigmine

Exelon (rivastigmine) Introduction and Regulatory Overview. Martina Struck, PhDSenior Associate Director Drug Regulatory Affairs Novartis Pharmaceuticals Corporation. Exelon (rivastigmine) in Alzheimer's Disease. Exelon is a slowly reversible cholinesterase inhibitorOriginal New Drug Applicatio

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Exelon rivastigmine

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    1. Exelon® (rivastigmine) United States Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory Committee May 17, 2006

    2. Exelon® (rivastigmine) Introduction and Regulatory Overview Martina Struck, PhD Senior Associate Director Drug Regulatory Affairs Novartis Pharmaceuticals Corporation

    3. Exelon® (rivastigmine) in Alzheimer’s Disease Exelon is a slowly reversible cholinesterase inhibitor Original New Drug Application Approved April 21, 2000, in US Mild to moderate dementia of the Alzheimer’s type (AD) Associated with cholinergic deficit Approved in > 80 countries

    4. Registration Studies Supporting Current Indication of AD Two randomized, double-blind, placebo-controlled studies US 26-wk study (N = 699) Global 26-wk study (N = 725) To date, 2.1 million patient-years of postmarketing exposure

    5. Exelon® (rivastigmine) in PDD Parkinson’s disease dementia Associated with cholinergic deficit No approved treatment—unmet medical need Supplemental New Drug Application Filed Aug 31, 2005, in US Proposed indication: Mild to moderate dementia associated with Parkinson’s disease Approvals in 39 countries (Feb 2006 in EU)

    6. Well-Controlled Study for Additional Indication of PDD EXPRESS Study 24-wk, randomized, multi-center, double-blind, placebo-controlled study with 24-wk open-label extension Met both primary endpoints Cognition: ADAS-cog Global assessment: ADCS-CGIC Most secondary endpoints such as activities of daily living, executive function, attention, and behavior are statistically significant

    7. Key Interactions With the FDA on PDD Dec 2001 and April 2004: Initial communication with FDA Define dementia in PD without ambiguity, using criteria that have wide acceptance and are both valid and reliable Delineate how patients with this entity differ from those with mild to moderate AD, to whom the currently approved claim for Exelon applies Jan 2005: Submitted “white paper” on diagnosing PDD and distinguishing it from AD May 2005: Meeting with FDA Aug 2005: sNDA submitted

    8. Objectives of Novartis Presentations To demonstrate that PDD is a distinct entity from AD and that PDD can be diagnosed using current clinical tools To demonstrate that the results from the EXPRESS study support the efficacy and safety of Exelon in the treatment of PDD and that these results are adequate to support the proposed indication

    9. Agenda

    10. Agenda

    11. Additional Consultants to Novartis

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