Anti-Infective Drugs Advisory Committee

Food and Drug Administration

Center for Drug Evaluation and Research

Hilton Gaithersburg, 620 Perry Parkway, Gaithersburg, MD

Biologic License Application (BLA) 125029

Xigris™ (drotrecogin alfa (activated)), Eli Lilly and Company

Agenda - October 16, 2001

8:30 Call to Order, Introductions: Barth Reller, M.D., Chair

Meeting Statement: Thomas H. Perez, M.P.H., Executive Secretary

Opening Comments: Gibbes Johnson, Ph.D., Chair, FDA Review Team

9:00 Eli Lilly and Company Presentation:


Holger Schilske, M.D., Ph.D. Executive Director, Eli Lilly and Company
Pathophysiology of Severe Sepsis Rationale for Drotrecogin Alfa (activated)
Steven Opal, MD Chief Infectious Disease Division Brown University School of Medicine
Efficacy and Safety of Drotrecogin Alfa (activated) in the Treatment of Severe Sepsis
William Macias, M.D., Ph.D. Medical Director, Eli Lilly and Company
Benefit-Risk Assessment of Drotrecogin Alfa (activated) in the Treatment of Severe Sepsis
Jeffrey Helterbrand, Ph.D. - Senior Statistical Scientist, Eli Lilly and Company
Clinical Experience in Pediatric Patients with Severe Sepsis and Overall Conclusions
William Macias, M.D., Ph.D. Medical Director, Eli Lilly and Company

10:30 Break

10:45 FDA Presentation:

Summary of Efficacy

Linda Forsyth, M.D., Medical Officer, Center for Biologics Evaluation and Research, FDA

Pediatric Data and Summary of Adult Safety

Robert Lindblad, M.D., Medical Officer, CBER, FDA

12:30 Lunch

1:30 Open Public Hearing

2:30 Charge to the Committee, Introduction to Questions:

3:30 Break

3:45 Discussion and Questions

5:00 Adjourn

Consultants and Guests

Thomas Fleming, Ph. D., Cardiorenal Drugs Advisory Committee Member

Robert Munford, M.D., Department of Internal Medicine, Univ. of Texas Southwestern Medical Center

H. Shaw Warren, M.D., Infectious Disease Unit, Massachusetts General Hospital

Anthony Suffredini M.D., Critical Care Medicine Department, National Institutes of Health

Leo C. Rotello, M.D., Medical Director, Surgical Intensive Care Unit, Surburban Hospital

Craig M. Lilly, M.D., Assistant Professor of Medicine, Brigham and Women's Hospital

Joseph A. Carcillo, M.D., Intensive Care Services Department, Children's Hospital of Pittsburgh

Peter Eichacker, M.D., Head, Critical Care Section, Warren G. Magnuson Clinical Center

W. Michael O'Fallon, Ph.D., Chair, Department of Health Sciences Research, Mayo Clinic



Open Public Hearing

William Lyons, M.D. (Representing Self)

Edward Wiginton, Meningitis Foundation of America

Alvin Lever, M.A., American College of Chest Physicians

Alvin Thomas Jr., M.D., American College of Chest Physicians

Thomas Smirniotopoulos M.D., (Representing Self)