Novartis (NVS) Announces Positive Data on Ultibro Breezhaler in COPD Flare-ups

September 6, 2016 7:35 AM EDT

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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-groups[1-10]. 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 severity[2], eosinophil levels (a type of white blood cells)[3] and previous inhaled corticosteroid (ICS) use[4,5], 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*** combination[6]. In addition, patients using Ultibro Breezhaler needed less rescue medication during the day[7].

"Earlier this year, the results from our major FLAME study demonstrated that Ultibro Breezhaler is superior to Seretide in reducing exacerbations and improving lung function," said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis (NYSE: NVS). "These new analyses of the data show the consistency of these findings across different patient sub-groups, including a post-hoc analysis in those previously using a triple therapy containing an ICS. This, combined with its safety profile, supports Ultibro Breezhaler as a suitable steroid-free treatment option for COPD patients at risk of exacerbation."

New analyses presented at ERS 2016 also showed that, compared to Seretide, Ultibro Breezhaler was associated with fewer systemic effects, namely impairment of adrenal function[8], 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 combination[11].

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 2016[12]. 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 interrelationship[12].

Novartis is presenting over 35 abstracts from across its broad respiratory portfolio at ERS 2016. The company is committed to continual clinical and patient-led research to address the evolving unmet needs of people living with respiratory diseases.

FLAME is a randomized, double-blind, double-dummy, parallel-group, non-inferiority, active-controlled 52-week study involving 3,362 COPD patients and conducted at 356 sites across 43 countries[11].

Results published in the New England Journal of Medicine[11] confirmed that Ultibro Breezhaler (indacaterol/glycopyrronium bromide) 110/50 mcg met its primary endpoint (non-inferiority) and furthermore demonstrated superiority to Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg on the rate of all COPD exacerbations (mild/moderate/severe) over one year of treatment in COPD patients with a history of at least one exacerbation in the previous year. Against further secondary endpoints, Ultibro Breezhaler was also superior compared to SFC in reducing or improving the following[11]:

  • Rate and time to first moderate or severe COPD exacerbation
  • Time to first COPD exacerbation (mild/moderate/severe)
  • Time to first severe COPD exacerbation
  • Lung function (trough FEV1)
  • Health-related quality of life (St. George's Respiratory Questionnaire)

FLAME is part of the IGNITE Phase III clinical trial program exploring Ultibro Breezhaler for the treatment of COPD.

About Ultibro Breezhaler
Ultibro Breezhaler (indacaterol/glycopyrronium bromide)110/50 mcg is a once-daily LABA***/LAMA**** dual bronchodilator approved in the European Union (EU) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD[13]. Clinical trials have shown that it offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including SFC 50/500 mcg[14-16] and open-label tiotropium (18 mcg). Ultibro Breezhaler is currently approved for use in over 90 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.

About the Novartis COPD portfolio
Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. The Novartis COPD portfolio includes Ultibro Breezhaler (indacaterol/glycopyrronium bromide), Seebri® Breezhaler® (glycopyrronium bromide) and Onbrez® Breezhaler®/ArcaptaTM NeohalerTM (indacaterol), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.

Novartis continues development of respiratory products for delivery via the low resistance Breezhaler® inhalation device, which makes it suitable for patients with different severities of airflow limitation[17]. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly[13,17].

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