In addition, an FDA meta-analysis of asthma-related serious adverse events in the four studies found a numerical imbalance in hospitalizations among adolescents: four hospitalizations among those on the combination drug, but none on fluticasone alone.
If approved, fluticasone-vilanterol would be the first once-daily inhaled ICS/LABA combination treatment for asthma. Fluticasone (100 mcg and 200 mcg) is approved for treating asthma. Unlike the LABAs salmeterol and formoterol, however, vilanterol is not approved for use as a single agent. Vilanterol (as part of the combination product) would be the first new LABA approved for asthma in 15 years.
The FDA usually follows the recommendations of its advisory panels; a decision is expected by April 30. Panelists had no disclosures.