Advair expanded COPD claim "not approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GlaxoSmithKline's sNDA for Advair Diskus (fluticasone/salmeterol inhalation powder) 500/50 mcg is "not approvable" for an expanded chronic obstructive pulmonary disease indication. FDA's Aug. 6 letter questions how the higher-dose 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 Pharmaceutical Approvals Monthly. 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...
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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. FDA's Aug. 6 letter questions how the higher-dose 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 Pharmaceutical Approvals Monthly. 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.... |