First presentation of LANTERN study to confirm superior efficacy of once-daily Ultibro® Breezhaler® versus Seretide® Accuhaler®* in COPD patients
QUANTIFY study to show superiority of Ultibro Breezhaler in lung function and shortness of breath versus tiotropium plus formoterol
New data from GLISTEN study will provide important evidence for the benefits of once-daily Seebri® Breezhaler® as add on therapy to LABA/ICS**
Novartis announced today that a wealth of new data from its respiratory portfolio will be presented at the European Respiratory Society (ERS) International Congress, September 6-10, in Munich, Germany. In total, 44 abstracts (including four late-breakers) will be presented by Novartis, representing more than any other company at the congress.
“Novartis is committed to making a difference to the lives of millions of people worldwide living with debilitating conditions, such as COPD and severe asthma,” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. “We hear from patients how their lives have improved because of our respiratory medicines, and this motivates us to continue to advance respiratory treatments in our portfolio.”
Positive new results from the Phase III head-to-head LANTERN study showed the superiority of once-daily, dual bronchodilator, Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide) in improving lung function compared to twice-daily Seretide® Accuhaler®* (salmeterol/fluticasone combination: LABA/ICS**), in patients with moderate-to-severe COPD.
Analyses from the QUANTIFY study demonstrated that Ultibro Breezhaler significantly improved lung function and shortness of breath in patients with moderate-to-severe COPD, compared to the combination of tiotropium plus formoterol. Results also showed that Ultibro Breezhaler is comparable to tiotropium plus formoterol in improving health-related quality of life.
Data from the GLISTEN trial showed that Seebri® Breezhaler® (glycopyrronium bromide) when added to LABA/ICS provided significant improvements in lung function, health status and rescue medication use in moderate-to-severe COPD patients when compared to LABA/ICS alone. This study provides much-needed evidence for add-on therapy to LABA/ICS in COPD, to support physicians care choices where very little data exist.
The safety profiles of Ultibro Breezhaler and Seebri Breezhaler were similar to those of their respective study comparators in the LANTERN, QUANTIFY and GLISTEN studies.
About the LANTERN Study
The primary objective of the LANTERN study was to demonstrate the non-inferiority of Ultibro Breezhaler to SFC in terms of lung function (trough FEV1) after 26 weeks of treatment in stable patients with moderate-to-severe COPD, with a history of one exacerbation or none in the previous year.
About the QUANTIFY Study
The primary objective of QUANTIFY was to demonstrate non-inferiority of Ultibro Breezhaler in HRQoL, as assessed by the St. George’s Respiratory Questionnaire-COPD (SGRQ-C), versus tiotropium plus formoterol after 26 weeks of treatment in patients with moderate-to-severe COPD2. Secondary endpoints included transition dyspnea index (TDI) score, trough FEV1, forced vital capacity (FVC) and safety and tolerability.
About the GLISTEN Study
The primary objective of GLISTEN was to demonstrate non-inferiority of Seebri Breezhaler 50 mcg versus tiotropium 18 mcg when added to salmeterol/fluticasone 50/500 mcg on trough FEV1 after 12 weeks of treatment in patients with moderate-to-severe COPD. The secondary endpoints included comparison of Seebri Breezhaler 50 mcg added to salmeterol/fluticasone compared with salmeterol/fluticasone plus placebo.
About Novartis in Respiratory
Novartis is committed to addressing the unmet medical needs of COPD and severe asthma patients and improving their quality of life by providing innovative medicines and devices. The Novartis respiratory 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. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly.
In addition, the portfolio also includes Xolair® for the treatment of severe persistent allergic asthma. Novartis co-promotes Xolair with Genentech/Roche in the US and shares a portion of the operating income, but does not book US sales.