CRESTOR  rosuvastatin calcium Tablets

CRESTOR rosuvastatin calcium Tablets PowerPoint PPT Presentation

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CRESTOR Introduction and Regulatory Overview. Mark S. Eliason, MScDirector, Regulatory Affairs. C. CI-3. Objectives of the Rosuvastatin Clinical Development Program. Provide an overall benefit-risk profile demonstratingGreater beneficial effects on key lipid parameters at both the start dose an

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CRESTOR rosuvastatin calcium Tablets

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1. CRESTOR® (rosuvastatin calcium) Tablets Endocrinologic and Metabolic Drugs Advisory Committee Bethesda, Maryland July 9, 2003

2. CRESTOR® Introduction and Regulatory Overview Mark S. Eliason, MSc Director, Regulatory Affairs

3. CI-3 Objectives of the Rosuvastatin Clinical Development Program Provide an overall benefit-risk profile demonstrating Greater beneficial effects on key lipid parameters at both the start dose and across the dose-range compared with marketed statins A similar safety profile compared with approved drugs in the statin class A low potential for significant drug-drug interactions

4. CI-4 Rosuvastatin Is a Hydrophilic Statin

5. CI-5 Rosuvastatin Human Pharmacokinetics Absorption Absolute bioavailability = 20.1% Tmax = 3 to 5 hr Distribution Vss = 134.0 L Plasma protein binding = 88% Metabolism Not extensively metabolized Elimination t˝ = 16 to 20 hr 90% in feces, 10% in urine

6. CI-6 The NDA Clinical Program Large international clinical trial program 33 phase I trials 27 phase II/III trials Doses of 5 to 80 mg studied in phase III 12,569 patients in safety database Phase III trial designs Comparisons with placebo, atorvastatin, simvastatin, pravastatin, niacin, fenofibrate Combinations with niacin, fenofibrate, and cholestyramine Open-label extension trials

7. CI-7 Important Features of the Rosuvastatin Clinical Development Program All clinical laboratory samples analyzed at 1 central laboratory in the phase III program Trials were designed to be inclusive No upper age limit for trials For most trials, the upper limit for creatinine was 2.5 mg/dL Women of childbearing potential participated Patients with comorbidities were included provided they were stable

8. CI-8 US Regulatory History (1) Initial NDA submission (June 2001) Proposed dose range of 10 to 80 mg In March 2002 AstraZeneca and Division agreed to Suspend 80-mg development Back-titrate 80-mg dose to 40 mg

9. CI-9 US Regulatory History (2) NDA Action Letter (May 2002) 10-mg, 20-mg, and 40-mg doses approvable Data requested on 600 patients for 20-mg and 40-mg doses each for 24 wk Additional information on renal effects NDA amendment submitted (February 2003) 12,569 patients in final phase II/III integrated database

10. CI-10 Proposed Indications Primary hypercholesterolemia and mixed dyslipidemia Hypertriglyceridemia Homozygous familial hypercholesterolemia

11. CI-11 Recommended Dosing of CRESTOR® The recommended starting dose of CRESTOR is 10 mg once daily, with a maximum recommended daily dose of 40 mg A 20-mg start dose is optional for patients with LDL-C > 190 mg/dL and aggressive lipid goals For homozygous familial hypercholesterolemia, the recommended starting dose of CRESTOR is 20 mg once daily A 5-mg dose will be made available for patients receiving cyclosporine

12. CI-12 Current Status of CRESTOR® Program Market approvals currently in 24 countries EU, Asia, and the Americas 10- to 40-mg dose range Ongoing trials program ~24,000 patients currently on rosuvastatin in ongoing trials in US and ROW Clinical outcomes trials (18,000 patients) initiated in May 2003

13. CI-13 Agenda for Presentation

14. CI-14 Consultant Representatives Daniel J. Rader, MD Associate Professor of Medicine University of Pennsylvania Christie M. Ballantyne, MD Professor of Medicine Baylor College of Medicine Donald B. Hunninghake, MD Professor Department of Pharmacology and Medicine (Cardiovascular) University of Minnesota Edmund J. Lewis, MD Director, Nephrology Professor of Medicine Rush-Presbyterian-St. Luke’s Medical Center Thomas Pearson, MD, PhD, MPH Professor/Chair/Associate Dean University of Rochester Medical Center Evan Stein, MD, PhD President and CEO Medical Research Laboratories International

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