Cardiovascular and Renal Drugs Advisory Committee

CDER Advisory Committee Conference Room, Room 1066

5630 Fishers Lane, Rockville, MD

November 16, 2005

Slides Presented During Meeting

The committee will discuss new drug application (NDA) 21-628, proposed trade name Certican® (everolimus) Tablets (0.25 mg, 0.50 mg, 0.75 mg and 1.0 mg), Novartis Pharmaceuticals Corporation, for the proposed indication of prophylaxis of rejection in heart transplantation.

Welcome [HTML] [PPT]	Renata Albrecht, M.D. Director Division of Special Pathogen and Transplant Products CDER, FDA
Novartis Pharmaceuticals Corporation Presentation:
Current Status and Future Challenges in Heart Transplantation [HTML] [PPT]	Marc L. Barr, M.D. Associate Professor of Cardiothoracic Surgery Co-Director, Cardiothoracic Transplantation University of Southern California and Children’s Hospital Los Angeles, California
Introduction and Regulatory Background [HTML] [PPT]	Mathias Hukkelhoven, Ph.D. Senior Vice President Global Head, Drug Regulatory Affairs Novartis Pharmaceuticals Corporation
Challenges and Opportunities In Cardiac Transplantation [HTML] [PPT]	Howard J. Eisen, M.D. Thomas J. Vischer Professor of Medicine Chief, Division of Cardiology Drexel University College of Medicine
Efficacy Results of Study B253 In De Novo Heart Transplantation [HTML] [PPT]	Jeffery D. Hosenpud, M.D. Clinical Professor of Medicine University of Wisconsin
Intravascular Ultrasound (IVUS) Results – Study B253 De Novo Transplantation [HTML] [PPT]	Jon A. Kobashigawa, M.D. Clinical Professor of Medicine and Cardiology Chief, Division of Clinical Faculty Medicine The David Geffen School of Medicine at UCLA Medical Director, UCLA Heart Transplant Program
Safety of Everolimus [HTML] [PPT]	Kenneth Somberg, M.D. Vice President Global Head of Clinical Research Transplantation and Immunology Novartis Pharmaceuticals Corporation
Renal Safety and Efficacy Extrapolation, Dose Recommendations [HTML] [PPT]	Lawrence G. Hunsicker, M.D. Professor of Medicine and Medical Director of Organ Transplantation Carver College of Medicine University of Iowa
Benefit/Risk Assessment [HTML] [PPT]	Howard J. Eisen, M.D.
Supporting Slides Presented During Presentation [HTML] [PPT]
Food and Drug Administration Presentation:
Statistical Overview of Study B253 [HTML] [PPT]	LT LaRee Tracy, M.A. Statistician Office of Biometrics Division of Biometrics 3, CDER
Safety and Efficacy of Everolimus [HTML] [PPT]	Arturo Hernandez, M.D Medical Officer Division of Special Pathogen and Transplant Products, CDER
Everolimus and Cyclosporine Exposure-Effectiveness and-Nephrotoxicity Relationships [HTML] [PPT]	Joga Gobburu, Ph.D. Team Leader, Pharmacometrics, Office of Clinical Pharmacology and Biopharmaceutics, CDER
Questions to the Committee [HTML] [PPT]