Food and Drug Administration

Center for Drug Evaluation and Research

Pulmonary-Allergy Drugs Advisory Committee

September 5, 2003

Holiday Inn, Gaithersburg




NDA 21-573, ArifloTM (cilomilast) Tablets 15mg, by GlaxoSmithKline, for use in Chronic Obstructive Pulmonary Disease (COPD)


8:00              Introductions                                                   Polly Parsons, M.D.

Conflict of Interest Statement                           Kimberly L. Topper, M.S.


8:20              Topic Introduction                                            Badrul Chowdhury, M.D.


8:30              GlaxoSmithKline Presentation

                    Introduction                                                     David Wheadon, M.D.

Rationale for the Use of Ariflo in COPD             Katharine Knobil, M.D.

                    Efficacy Data from Ariflo Clinical Program         Katharine Knobil, M.D.

                    Safety of Ariflo                                                Kathy Rickard, M.D.

                    Assessment of Outcome in COPD                    Frank Sciurba, M.D.

                    Conclusion                                                      David Wheadon, M.D.


9:30              Committee Discussion and Clarification  


10:00            Break


10:15            Food and Drug Administration Presentation

Introduction                                                     Raymond Anthracite, M.D.

                    Preclinical Pharmacology-Toxicology                 Virgil Whitehurst, Ph.D.

                    Dose-Finding                                                   Sandra Suarez-Sharp, Ph.D.

                    Statistics                                                         James Gebert, Ph.D.

                    Efficacy & Safety                                             Raymond Anthracite, M.D.


11:15            Committee Discussion and Clarification


11:45            Lunch


1:00              Open Public Hearing


2:00              Committee Discussion


3:00              Break


3:15              Questions


5:30              Adjourn