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.



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Renata Albrecht, M.D.


Division of Special Pathogen and Transplant Products



Novartis Pharmaceuticals Corporation Presentation:

Current Status and Future Challenges in Heart Transplantation

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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

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Mathias Hukkelhoven, Ph.D.

Senior Vice President

Global Head, Drug Regulatory Affairs

Novartis Pharmaceuticals Corporation


Challenges and Opportunities In Cardiac Transplantation

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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

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Jeffery D. Hosenpud, M.D.

Clinical Professor of Medicine

University of Wisconsin

Intravascular Ultrasound (IVUS) Results – Study B253 De Novo Transplantation

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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

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Kenneth Somberg, M.D.

Vice President

Global Head of Clinical Research

Transplantation and Immunology

Novartis Pharmaceuticals Corporation


Renal Safety and Efficacy Extrapolation, Dose Recommendations

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Lawrence G. Hunsicker, M.D.

Professor of Medicine and Medical Director of Organ Transplantation

Carver College of Medicine

University of Iowa


Benefit/Risk Assessment

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Howard J. Eisen, M.D.


Supporting Slides Presented During Presentation

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Food and Drug Administration Presentation:


Statistical Overview of Study B253

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LT LaRee Tracy, M.A.


Office of Biometrics

Division of Biometrics 3, CDER


Safety and Efficacy of Everolimus

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Arturo Hernandez, M.D

Medical Officer

Division of Special Pathogen and Transplant Products, CDER


Everolimus and Cyclosporine Exposure-Effectiveness and-Nephrotoxicity Relationships

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Joga Gobburu, Ph.D.

Team Leader, Pharmacometrics,

Office of Clinical Pharmacology and Biopharmaceutics, CDER


Questions to the Committee

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