Press release
May 16, 2016

Major study published in NEJM confirms Ultibro® Breezhaler® superiority over Seretide in preventing COPD exacerbations


  • FLAME study showed consistent superiority of Ultibro® Breezhaler® over Seretide® across exacerbation outcomes, lung function and health-related quality of life in COPD patients 
  • Ultibro Breezhaler also significantly reduced the rate and prolonged the time to the first moderate or severe exacerbation, compared to Seretide 
  • Results published in the New England Journal of Medicine are anticipated to have important implications for the care of people living with COPD

Tokyo, Japan – 16 May 2016: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the announcement by Novartis yesterday of 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 outcomes1. The published FLAME results are anticipated to impact the future management and treatment of COPD patients.

Preventing exacerbations is one of the primary goals of long-term care for COPD patients. These episodes have a detrimental effect on quality of life and disease progression2, contributing to further lung function decline3,4 and, in severe cases, hospitalization5 and even death2.

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)1. 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 (hazard ratio, 0.78)1. 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)1.

These data were also presented to the scientific community for the first time yesterday at the 2016 Annual Meeting of American Thoracic Society (ATS) in San Francisco, USA.

 

References

1. Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol/Glycopyrronium Versus Salmeterol/Fluticasone for COPD Exacerbations. New England Journal of Medicine. 2016. Available at: www.nejm.org/doi/full/10.1056/NEJMoa1516385 [Accessed 15 May 2016].

2. Soler-Cataluña JJ, Martinez-Garcia MA, Sanchez PR, et al. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax. 2005;60:925-931.

3. Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002;57:847-52.

4. Vestbo J, Edwards LD, Scanlon PD, et al. Changes in forced expiratory volume in 1 second over time in COPD. N Engl J Med. 2011;365:1184-92.

5. Müllerova H, Maselli DJ, Locantore N, et al. Hospitalized exacerbations of COPD: risk factors and outcomes in the ECLIPSE cohort. Chest. 2015;147:999-1007.

6. Clinicaltrials.gov. QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study (FLAME). NCT01782326. Available at: https://clinicaltrials.gov/ct2/show/NCT01782326?term=NCT01782326&rank=1 [Accessed 10 March 2016].

7. Ultibro Breezhaler EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002679/ WC500151255.pdf [Accessed 10 March 2016]. 


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