Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Antiviral Drugs Advisory Committee
Hilton
The Antiviral Drugs Advisory Committee will discuss new
drug application (NDA) 021-814, proposed tradename Aptivus (Tipranavir) 250
milligrams (mg) capsules, Boehringer Ingelheim Pharmaceuticals, Inc., indicated for the
treatment of patients with HIV.
Chair
Introduction
of Committee
Conflict of
Interest Statement Anuja Patel, M.P.H.
Executive
Secretary, FDA
Director, Division of Antiviral
Drug Products (DAVDP)
Boehringer Ingelheim
Pharmaceuticals, Inc.
·
Introduction Burkhard Blank, M.D.
Senior Vice President Medicine/DRA
·
Tipranavir Development Douglas Mayers, M.D.
International Head, Therapeutic
Area Virology
·
Efficacy and Drug: Scott McCallister,
M.D.
Drug Interactions Global Medical
Team Leader, TPV
·
Safety Christopher
Corsico, M.D.
Head, Drug Surveillance and
Information
·
Resistance Douglas
Mayers, M.D.
International
Head, Therapeutic Area Virology
·
Potential Utility of Tipranavir Daniel Kuritzkes,
M.D.
In Current Clinical Practice Director of AIDS Research,
Brigham
and Women’s Hospital,
Division
of AIDS,
Associate Professor of Medicine,
·
Conclusions Burkhard Blank, M.D.
Senior Vice President Medicine/DRA
Division
of Antiviral Drug Products
·
Efficacy Evaluation Rafia Bhore, Ph.D.
Statistical
Reviewer
·
Resistance Evaluation Lisa Naeger, Ph.D.
Senior Microbiology Reviewer
·
Exposure-Response Data Jenny J. Zheng, Ph.D.
Pharmacometrics
Reviewer
·
Drug Interactions Yuanchao
(Derek) Zhang, Ph.D.
Clinical Pharmacology and Biopharmaceutics Reviewer
·
Safety Profile and Conclusions Andrea James, M.D.
Medical Reviewer
Open Public Hearing