Presentation is loading. Please wait.

Presentation is loading. Please wait.

CI-1 Ranexa™ (ranolazine) Extended Release Tablets Michael Sweeney, MD, FRCP VP, Medical Affairs CV Therapeutics, Inc. Cardiovascular and Renal Drugs Advisory.

Similar presentations


Presentation on theme: "CI-1 Ranexa™ (ranolazine) Extended Release Tablets Michael Sweeney, MD, FRCP VP, Medical Affairs CV Therapeutics, Inc. Cardiovascular and Renal Drugs Advisory."— Presentation transcript:

1 CI-1 Ranexa™ (ranolazine) Extended Release Tablets Michael Sweeney, MD, FRCP VP, Medical Affairs CV Therapeutics, Inc. Cardiovascular and Renal Drugs Advisory Committee Meeting December 9, 2003

2 CI-2 Ranexa TM (ranolazine) A Unique Anti-Anginal Pharmacodynamic Profile  Anti-anginal and anti-ischemic efficacy demonstrated  Novel pharmacodynamic profile: anti-ischemic properties do not depend on changes in – Heart rate – Blood pressure  Complementary therapy to existing agents that depend on hemodynamic mechanisms

3 CI-3 Ranexa™ (ranolazine) Proposed Indication and Dosing The sponsor seeks approval of Ranexa for the  Treatment of chronic angina in patients with severe coronary artery disease  Usual starting dose 500 mg bid, with upward titration to 750 mg and 1000 mg bid as needed

4 CI-4 Benefit-Risk Benefit  Anti-anginal and anti-ischemic efficacy  Achieved with minimal hemodynamic effects  Well tolerated Risk  Adverse events  Theoretical risk of TdP due to prolongation of QTc

5 CI-5 Ranexa™ (ranolazine)— Effects on Ventricular Repolarization  Extensively studied clinical and preclinical EP profile  Small, dose-related mean increases in QTc – 2 to 5 msec over proposed dose range – Up to 20 msec under maximal inhibition of CYP3A4  Ranolazine and preclinical markers of torsadogenic risk – No early afterdepolarizations (EADs) – No increased dispersion of ventricular repolarization – Reverses these effects when caused by other drugs  No case of TdP in clinical development

6 CI-6 Ranexa™ (ranolazine) for Chronic Angina—Sponsor Presentation Unmet Medical NeedEugene Braunwald, MD, FACC Brigham and Women’s Hospital Clinical Efficacy and SafetyAndrew Wolff, MD, FACC Sr VP, Clinical R&D Surrogate Markers of Pro-Arrhythmic Risk Peter Kowey, MD, FACC Lankenau Hospital and the Main Line Health System Jefferson Medical College Mechanistic Assessment of Repolarization Effects Luiz Belardinelli, MD VP, Drug Research and Pharmacological Sciences Clinical Assessment of Repolarization Effects Andrew Wolff, MD, FACC Sr VP, Clinical R&D Benefit/RiskJeremy Ruskin, MD, FACC Massachusetts General Hospital

7 CI-7 Advisors and Consultants (1) Charles Antzelevitch, PhD, FACCMasonic Medical Research Laboratory Utica, NY John Camm, MD, FACCSt. George’s Hospital Medical School London, England Bernard Chaitman, MD, FACCSt. Louis University School of Medicine St. Louis, MO Gary Koch, PhDUniversity of North Carolina Chapel Hill, NC Samuel Lee, MD, FRCPCUniversity of Calgary Calgary, Alberta, Canada Marek Malik, MD, PhD, FACCSt. George’s Hospital Medical School London, England

8 CI-8 Advisors and Consultants (2) Craig M. Pratt, MD, FACCBaylor College of Medicine Houston, TX Dan Roden, MD, FACCVanderbilt University School of Medicine Nashville, TN Peter Stone, MD, FACCBrigham and Women’s Hospital Boston, MA


Download ppt "CI-1 Ranexa™ (ranolazine) Extended Release Tablets Michael Sweeney, MD, FRCP VP, Medical Affairs CV Therapeutics, Inc. Cardiovascular and Renal Drugs Advisory."

Similar presentations


Ads by Google