Pulmonary-Allergy Drugs Advisory Committee Meeting

 

May 01, 2007

 

The Committee discussed the benefit to risk considerations for the approved product Advair Diskus 500/50 (fluticasone propionate/salmeterol inhalation powder) to increase survival and reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD) (NDA 21-077 efficacy supplement).

 

Slides

 

Glaxo Smith Kline Presentation

 

Advair Diskus 500/50 (fluticasone propionate and salmeterol inhalation powder), Elaine Jones, Ph.D., Vice President, US Regulatory Affairs, GlaxoSmithKline (PPT) (HTM)

 

Efficacy and Safety Data from the Advair Diskus 500/50 Clinical Program, Katharine Knobil, MD., Vice President, Respiratory Clinical Development, GlaxoSmithKline (PPT) (HTM)

 

Clinician’s Perspective, Bartolome Celli, M.D., Professor of Medicine, Tufts University (PPT) (HTM)

 

Closing Remarks, Elaine Jones, Ph.D., Vice President, U.S Regulatory Affairs, GlaxoSmithKline (PPT) (HTM)

 

Back up Slides (PPT) (HTM)

 

Food and Drug Administration Presentation

 

History of the Clinical Program for Advair Diskus 500/50 and Introduction to the Efficacy Data, Carol Bosken, M.D., ScM, MPH, Division of Pulmonary and Allergy Products (PPT) (HTM)

 

Efficacy Data for Advair Diskus 500/50, Feng Zhou, M.S., DBII/ Office of Biostatistics (PPT) (HTM)

 

Safety Data for Advair Diskus 500/50 and Summary, Carol Bosken, M.D., ScM, MPH, Division of Pulmonary and Allergy Products (PPT) (HTM)