• Ultibro® Breezhaler® reduced rate of all COPD exacerbations across different patient sub-groups vs Seretide® in new analyses from FLAME study
• Analyses show that Ultibro® Breezhaler® lowered patients’ need for rescue medication and had improved benefit-risk profile compared to Seretide®, with less evidence of systemic effects
• Sub-group analyses of FLAME and a retrospective large-scale study showing potential relationship between inhaled corticosteroid use and pneumonia are being shared at ERS 2016
Chippenham, UK – 5 September 2016: Vectura Group plc (LSE: VEC) (“Vectura”), an industry-leading inhaled airways disease focused business, confirms the announcement by our alliance partner Novartis that new analyses from the head-to-head FLAME study confirmed that Ultibro® Breezhaler® is a more effective option for patients at risk of chronic obstructive pulmonary disease (COPD) flare-ups (exacerbations) than Seretide®, across different patient sub-groups1-10. These findings are being presented at the 2016 European Respiratory Society (ERS) International Congress this week in London, UK.
In the new analyses, once-daily Ultibro® Breezhaler® 110/50 mcg demonstrated consistent reductions in the rate of all exacerbations (mild, moderate and severe)1, regardless of age, smoking status, exacerbation history, disease severity2, eosinophil levels (a type of white blood cells)3 and previous inhaled corticosteroid (ICS) use4,5, versus twice-daily Seretide® 50/500 mcg. Specifically, among patients with the severest forms of COPD**, Ultibro® Breezhaler® significantly reduced the rate of exacerbations and improved their health status versus the commonly used ICS/LABA*** combination6. In addition, patients using Ultibro® Breezhaler® needed less rescue medication during the day7.
New analyses presented at ERS 2016 also showed that, compared to Seretide®, Ultibro® Breezhaler® was associated with fewer systemic effects, namely impairment of adrenal function8, which regulates the natural production of hormones. Ultibro® Breezhaler® use has previously shown to be associated with significantly fewer cases of pneumonia than the ICS/LABA combination11.
Adding evidence to the need to reduce the risks of chronic ICS therapy, results of a large retrospective observational study involving >87,000 participants (with and without COPD) from Sweden are also being shared at ERS 201612. The ARCTIC study found that COPD patients were at greater risk of pneumonia than those without the disease, but that this risk was even higher for those taking an ICS (whether at a low or high dose)12. Even people without COPD that took an ICS increased their risk of pneumonia, further demonstrating their interrelationship12.
Novartis is presenting over 35 abstracts from across its broad respiratory portfolio at ERS 2016.
James Ward-Lilley, Vectura’s CEO, commented:
“These new findings further demonstrate the superior efficacy of Ultibro® Breezhaler® versus Seretide® across a range of patient sub-groups and support its use as a steroid-free treatment option for COPD patients at risk of exacerbations. This, combined with the existing efficacy and safety profile of Ultibro® Breezhaler® further confirms our confidence in its outlook”
