Food and Drug Administration

Center for Drug Evaluation and Research (CDER)


Antiviral Drugs Advisory Committee


May 19, 2005



620 Perry Parkway

Gaithersburg, Maryland


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.


8:00                 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



8:10                 Overview of Issues                                           Debra B. Birnkrant, M.D.

Director, Division of Antiviral Drug Products (DAVDP)


8:15                 Sponsor Presentations

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,

                                                                                                Harvard Medical School


·        Conclusions                                          Burkhard Blank, M.D.

Senior Vice President Medicine/DRA

9:30                 Break


9:45                 FDA Presentations

                        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


11:15               Questions from the Committee to the Sponsor and FDA


Noon               Lunch


1:00                 Awards Presentation


                        Open Public Hearing


2:00                 Continue Discussion and Questions to the Committee


5:00                 Adjourn