Advair Survival Claim In Question; Data Not Robust, But Can’t Confirm – Cmte.
Executive Summary
In reaching a decision about whether to approve a survival claim GlaxoSmithKline's Advair,FDA will have to weigh the Pulmonary-Allergy Drugs Advisory Committee's concerns about the robustness of the findings of the single trial that has been conducted with the panel's predictions that it may be impossible to conduct a confirmatory survival study
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GlaxoSmithKline's sNDA for Advair Diskus (fluticasone/salmeterol inhalation powder) 500/50 mcg is "not approvable" for an expanded chronic obstructive pulmonary disease indication. In an Aug. 6 letter, FDA questions how the higher-dosing form of the long-acting beta agonist bronchodilator compares with the approved Advair 250/50 mcg strength. GSK does not have head-to-head data comparing the two formulations, the firm tells "The Pink Sheet." FDA's Pulmonary-Allergy Drugs Advisory Committee issued a mixed review of the product May 1, voting 9-2 that GSK's pivotal trial failed to provide "substantial convincing evidence" that the 500/50 dose increased COPD survival (1"The Pink Sheet" May 7, 2007, p. 12)...