FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

Endocrinologic and Metabolic Drugs Advisory Committee Meeting

June 10, 2003

Holiday Inn, Versailles Ballroom, Bethesda, Maryland

AGENDA

8:30 − 8:45 a.m. Call to Order and Introductions Glenn Braunstein, M.D.

Chair, Endocrinologic and Metabolic Drugs Advisory Committee

Conflict of Interest Statement Dornette Spell-LeSane, A.N.P., M.H.A.

Executive Secretary, EMDAC

8:45 − 9:00 a.m. Welcome and Introductory Comments David Orloff, M.D.

Division of Metabolic and Endocrine Drug Products, FDA

__________________________________________________________________________________________

sNDA 19-640/S-033, Humatrope® (somatropin [rDNA origin] for injection), Eli Lilly and Company

Proposed for the indication of non-gGrowth hormone deficient short stature

9:00 a.m. Sponsor Presentation

Introduction Gregory Enas, Ph.D.

Director, US Regulatory Affairs

Eli Lilly and Company

Rationale for treatment Raymond Hintz, M.D.

Professor of Pediatrics

Stanford University Medical Center

Efficacy Gordon Cutler, M.D.

Director, Growth and Recovery Research

and Clinical Investigation

Eli Lilly and Company

Safety Charmian Quigley, M.B.B.S.

Senior Clinical Research Physician

Endocrinology

Eli Lilly and Company

Endocrinologic and Metabolic Drugs Advisory Committee Meeting

June 10, 2003

Agenda (cont.)

Sponsor Presentation (cont.)

Benefit-Risk Assessment Charmian Quigley, M.B.B.S.

and Risk Management Plan

Concluding Statements Margaret MacGillivray, M.D.

Professor of Pediatrics

University of Buffalo

Pediatric Endocrinologist

School of Medicine & Biomedical Sciences

Children’s Hospital Buffalo

10:45 − 10:55 a.m. Break

10:55 − 11:30 a.m. Committee Discussions

11:30 − 12:00 p.m. Presentation Harvey John Guyda, B.Sc. (Med), M.D., FRCPC

Professor, Department of Pediatrics

McGill University

12:00 − 12:30 p.m. Committee Discussion

12:30 − 1:30 p.m. Lunch

1:30 − 2:30 p.m. Open Public Hearing

2:30 − 2:45 p.m. Charge to the Committee

David Orloff, M.D.

Division Director

Metabolic and Endocrine Drug Products

FDA

2:45 − 3:45 p.m. Committee Discussion/Questions

Break

Committee Discussion/Questions/Summary

5:00 p.m. Adjournment