Results of FLAME trial of Ultibro Breezhaler (indacaterol / glycopyrronium bromide) in chronic obstructive pulmonary disease published in New England Journal of Medicine- Novartis

Novartis has announced the New England Journal of Medicine publication of the head-to-head FLAME study comparing the efficacy of once-daily Ultibro Breezhaler (indacaterol/glycopyrronium bromide) 110/50 mcg to twice-daily Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg in reducing chronic obstructive pulmonary disease (COPD) exacerbations. In addition to meeting the primary endpoint (non-inferiority), findings demonstrated the superiority of Ultibro Breezhaler over the widely used inhaled corticosteroid (ICS)/LABA combination on exacerbation outcomes. The published FLAME results are anticipated to impact the future management and treatment of COPD patients.

The results of FLAME confirmed that Ultibro Breezhaler is superior to SFC in reducing exacerbation outcomes regardless of a patient's disease severity and eosinophil levels (a type of white blood cell). Significantly, compared to SFC, Ultibro Breezhaler both reduced the rate of moderate or severe exacerbations with a 17% risk reduction (rate ratio, 0.83), and prolonged the time to the first of these episodes with a 22% risk reduction. The safety profiles of the two treatments were consistent with their known profiles. The incidence of pneumonia was higher with SFC than Ultibro Breezhaler (3.2% vs 4.8%: a statistically significant difference). These data were also presented at the 2016 Annual Meeting of American Thoracic Society.

Comment: Ultibro Neohaler (Ultibro Breezhaler in EU, where the combination was approved in 2014) offers patients a substantial advantage with its once-daily dosing formulation. The once-daily formulation will encourage patients currently taking single-formulation LAMAs and LABAs to switch to this new formulation as they seek to simplify their treatment regimens, which is expected to improve compliance and therefore improve outcomes to therapy.