GlaxoSmithKline (GSK) said that FDA has rejected the drugmaker's supplemental drug application for the 500/50 strength of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) to treat patients with chronic obstructive pulmonary disease (COPD).
GSK said the FDA raised questions about dosing levels proposed by the drugmaker.
The drugmaker said it will be meeting with FDA to discuss Advair and the decision in more detail and determine next steps.
"We are very surprised and disappointed by this FDA decision particularly given the outcome of the FDA advisory committee meeting earlier this year," Katharine Knobil, MD, VP of respiratory clinical development for COPD at GSK said in a statement. "The advisory committee voted unanimously that Advair 500/50 demonstrated a significant reduction in the risk of exacerbations. We believe in the strength of the data. This application is based on the results of the largest COPD study conducted in more than 6,000 patients over three years. We are committed to working with the FDA to address any questions they have and to pursue a way forward."
Advair is GSK's best-selling respiratory drug with sales of $3.3 billion for 2006. Its main competitor is Merck's Singulair.