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 Patientís 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.†††††††††††††† Questionsfrom 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††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††