FDA Says New Advair Dose Not Approvable

The FDA has issued a “not approvable” letter for GlaxoSmithKline’s sNDA for the 500/50 strength of Advair Diskus for the treatment of chronic obstructive pulmonary disease (COPD). Specifically, the agency questioned how the new dose compared to the currently approved 250/50 strength in order to allow for appropriate dosing recommendations. GSK will be meeting with FDA to discuss this request and determine next steps, including discussion of GSK’s recent data on the reduction of exacerbations with the Advair 250/50 strength.

“We are very surprised and disappointed by this FDA decision, particularly given the outcome of the FDA advisory committee meeting earlier this year,” said Katharine Knobil, M.D., vice president of respiratory clinical development for COPD at GSK. “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.”