Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Antiviral Drugs Advisory Committee
The Antiviral Drugs Advisory Committee will discuss new drug applications (NDAs) 21-797 and 21-798, entecavir tablets and entecavir oral solution, respectively, Bristol-Myers Squibb Company, proposed for the treatment of patients with chronic hepatitis B infection (HBV).
Call to Order and Opening Remarks Janet Englund, M.D.
Introduction of Committee
Conflict of Interest Statement Anuja Patel, M.P.H.
Executive Secretary, FDA
Overview of Issues Debra B. Birnkrant, M.D.
Director, Division of Antiviral Drug Products (DAVDP)
Bristol-Myers Squibb Company
· Introduction Elliott Sigal, M.D., Ph.D.
Chief Scientific Officer & President,
Pharmaceutical Research Institute
· Background Richard Wilber, M.D.
· Nonclinical Safety Lois Lehman-McKeeman, Ph.D.
Distinguished Research Fellow,
· Clinical/Efficacy and Safety Helena Brett-Smith, M.D.
Infectious Diseases Clinical Research
· Resistance Richard Colonno, Ph.D.
Infectious Diseases Drug Discovery
· Benefit vs. Risk Assessment Donna Morgan Murray, Ph.D.
Global Regulatory Sciences
Questions from the Committee
Division of Antiviral Drug Products
· Carcinogenicity Issues James G. Farrelly, Ph.D.
Pharmacology Team Leader, DAVDP
· Clinical Issues Linda L. Lewis, M.D.
Lead Medical Officer, DAVDP
Open Public Hearing
Continue Discussion and Questions to the Committee