FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ARTHRITIS ADVISORY COMMITTEE (AAC) MEETING

JUNE 23-24, 2003

AGENDA

Versailles Ballroom, Holiday Inn, Bethesda, MD

June 23, 2003

8:00 a.m. Call to Order Gary S. Firestien, M.D.

Chair, AAC

Introduction of Committee

Conflict of Interest Statement Johanna Clifford, M.S., RN, BSN

Acting Executive Secretary, AAC

8:15 a.m. Opening Remarks

Discussion of Fibrolmyalgia, clinical trial design, including important disease endpoints, in the study and development therapies and treatments.

Historical Background of Fibromyalgia

8:45 a.m. Pre ACR Diagnostic Criteria

9:15 a.m. Basic Mechanisms

9:45 a.m. Post ACR Diagnostic Criteria

10:30 a.m. Break

10:45 a.m. A Patient’s Perspective

11:00 a.m. Outcomes: Multi-System Impact

11: 30 Open Public Hearing

12:00 p.m. Lunch

1:00 p.m. Charge to Committee

1:30 p.m. Committee Discussion and Response to FDA Questions

2:30 p.m. Break

4:30 p.m. Adjourn

June 24, 2003

8:00 a.m. Call to Order Howard J. Williams, M.D.

Acting Chair, AAC

Introduction of Committee

Conflict of Interest Statement Johanna Clifford, M.S., RN, BSN

Acting Executive Secretary, AAC

Discussion of Enbrel (etanercept) indicated for reducing the signs and symptoms of ankylosing spondylitis.

8:15 a.m. Amgen Presentation

Introduction

Assessments in Ankylosing Spondylitis

Clinical Program and Results

Benefit/Risk Assessment

9:15 am. Questions from the Committee Sponsor

9:45 a.m. Break

10:00 a.m. FDA Presentation

11:00 a.m. Questions from the Committee to FDA

11:30 a.m. Open Public Hearing

12:00 p.m. Lunch

1:00 p.m. Committee Discussion and Response to FDA Questions

2:00 p.m. Break

2:15 p.m. Continuation of Committee Discussion and Response to FDA Questions

4:30 p.m. Adjourn