Food and Drug Administration

Center for Drug Evaluation and Research

Endocrinologic and Metabolic Drugs Advisory Committee

Holiday Inn Bethesda

8120 Wisconsin Avenue, Bethesda, MD

Agenda

July 26, 2001

NDA 21-332, Symlin ä (pramlintide acetate) Amylin Pharmaceuticals, Inc.

 

8:00 Call to Order and Introductions: Robert A. Kreisberg, M.D., Acting Chair

Meeting Statement: Kathleen Reedy, Executive Secretary

8:15 Welcome and Introduction: David G. Orloff, M.D., Director

Division of Metabolic and Endocrine Drug Products

8:30 Amylin Pharmaceuticals, Inc. Presentation

Overview: Joann L. Data, MD,PhD, Sr.VP Regulatory Affairs and Quality Assurance

Unmet Medical Need: Kenneth Polonsky, MD, Adolphus Busch Professor of Medicine

Chairman, Department of Medicine, Washington University School of Medicine

Pharmacology of Pramlintide: Andrew Young, MD, PhD, VP, Research at Amylin

Clinical Program for Pramlintide: Orville Kolterman, MD, Sr. VP Clinical Affairs at Amylin

Risk/Benefit/Summary: Alain Baron, VP Clinical Research at Amylin

10:00 Break

10:15 FDA Presentation: Division of Metabolic and Endocrine Drug Products

Efficacy: Robert I. Misbin, M.D.

Safety: Dragos G. Roman, M.D.

11:15 Open Public Hearing

11:45 Lunch

1:00 Charge to the Committee: David G. Orloff, M.D., Director

Division of Metabolic and Endocrine Drug Products

Discussion and Questions:

Break

4:30 Summary and Review

5:00 Adjourn