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 |
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 |
Marc L. Barr, M.D. Associate Professor of Cardiothoracic Surgery Co-Director, Cardiothoracic Transplantation |
Introduction and Regulatory Background |
Mathias
Hukkelhoven, Ph.D. Senior Vice President Global Head, Drug Regulatory
Affairs Novartis Pharmaceuticals Corporation |
Challenges and Opportunities In Cardiac Transplantation |
Howard J. Eisen, M.D. Thomas J. Vischer Professor of
Medicine Chief, Division of Cardiology |
Efficacy Results of Study B253 In De Novo Heart Transplantation |
Jeffery
D. Hosenpud, M.D. Clinical Professor of Medicine |
Intravascular Ultrasound (IVUS) Results
– Study B253 De Novo Transplantation |
Jon A. Kobashigawa, M.D. Clinical Professor of Medicine and
Cardiology Chief, Division of Clinical
Faculty Medicine The Medical Director, UCLA Heart
Transplant Program |
Safety of Everolimus |
Kenneth
Somberg, M.D. Vice President Global Head of Clinical Research Transplantation and Immunology Novartis Pharmaceuticals
Corporation |
Renal Safety and Efficacy Extrapolation, Dose Recommendations |
Professor of Medicine and Medical
Director of Organ Transplantation |
Benefit/Risk Assessment |
Howard J. Eisen, M.D. |
Supporting Slides Presented During Presentation |
|
Food and Drug Administration
Presentation: |
|
Statistical Overview of Study B253 |
LT LaRee Tracy, M.A. Statistician Office of Biometrics Division of Biometrics 3, CDER |
Safety and Efficacy of Everolimus |
Arturo Hernandez, M.D Medical Officer Division of
Special Pathogen and Transplant Products, CDER |
Everolimus and Cyclosporine Exposure-Effectiveness and-Nephrotoxicity
Relationships |
Joga Gobburu, Ph.D. Team Leader, Pharmacometrics, Office of Clinical Pharmacology
and Biopharmaceutics, CDER |
Questions to the Committee |
|