Food and Drug Administration
Center for Drug Evaluation and Research
Endocrinologic and Metabolic Drugs Advisory Committee
Holiday Inn
8170 Wisconsin Avenue
Bethesda, Maryland
Agenda
January 13-15, 20038:00 Call to Order and Opening Remarks Thomas Aoki, M.D.
Acting Chair, EMDAC
Introduction of Committee
Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
Acting Executive Secretary, EMDAC
BL 103979, Fabrazyme™ (agalsidase beta), Genzyme Corporation
- proposed for the treatment of Fabry’s disease
8:10 Introduction CBER
8:15 Sponsor Presentation Genzyme Corporation
9:15 Questions from the Committee
9:45 Break
10:00 FDA Presentation
11:00 Questions from the Committee
11:30 Open Public Hearing
12:30 Lunch
1:30 Committee Discussion and Vote
5:00 Estimated Time of Adjournment
January 14, 2003
8:00 Call to Order and Opening Remarks Thomas Aoki, M.D.
Acting Chair, EMDAC
Introduction of Committee
Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
Acting Executive Secretary, EMDAC
BL 103977, ReplagalÔ (agalsidase alfa) - Transkaryotic Therapies, Inc.
- proposed for the treatment of Fabry’s disease
8:10 Introduction CBER
8:15 Sponsor Presentation Transkaryotic Therapies, Inc.
9:15 Questions from the Committee
9:45 Break
10:00 FDA Presentation
11:00 Questions from the Committee
11:30 Open Public Hearing
12:30 Lunch
1:30 Committee Discussion and Vote
5:00 Estimated Time of Adjournment
January 15, 2003
8:00 Call to Order and Opening Remarks Thomas Aoki, M.D.
Acting Chair, EMDAC
Introduction of Committee
Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
Acting Executive Secretary, EMDAC
BL 125058, AldurazymeÔ (laronidase), BioMarin Pharmaceutical Inc.
-proposed for the treatment of mucopolysaccharidosis
8:10 Introduction CBER
8:15 Sponsor Presentation BioMarin Pharmaceutical Inc.
9:15 Questions from the Committee
9:45 Break
10:00 FDA Presentation
11:00 Questions from the Committee
11:30 Open Public Hearing
12:30 Lunch
1:30 Committee Discussion and Vote
5:00 Estimated Time of Adjournment