|DATE:||October 29, 2015|
|TIME:||1:30 - 2:50 pm|
|LOCATION:||Medical School Office Building, Rm x303|
|TITLE:||An Example to Show Importance of Benefit/Risk Assessment in Drug Development|
Biostatistics Manager at Gilead Science
(Former Mathematical Statistician at FDA)
In July 2011, the Food and Drug Administration (FDA) approved Arcapta Neohaler (indacaterol maleate powder), a long-acting beta-agonist (LABA), at a dose of 75 µg once daily as a bronchodilator for patients with chronic obstructive pulmonary disease (COPD). Since the European Medicines Agency (EMA) had approved indacaterol at doses of 150 µg and 300 µg in 2009, one might question why the FDA selected a 75-µg dose. This talk is to summarize the statistical review on dose selection issue for this drug and answer the question why the FDA approved the 75-µg dose.
Badrul A Chowdury, Sally M Seymour, Theresa M Michele, Dongmei Liu et al. (2011). The Risks and Benefits of Indacaterol N Engl J Med, 365:2274-2249.