Novartis announced positive first results from the phase III head-to-head LANTERN study, which showed the superiority of once-daily Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg in improving lung function compared to twice-daily Seretide Accuhaler (salmeterol/fluticasone (SFC)) 50/500 mcg in COPD patients with or without a history of moderate-to-severe exacerbations in the previous year. Ultibro Breezhaler met both the primary and key secondary objectives.
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 patients with moderate-to-severe COPD, with or without a history of moderate-to-severe exacerbations in the previous year. Ultibro Breezhaler demonstrated non-inferiority and additionally showed superior efficacy versus SFC for the primary objective. These results will be part of the regulatory submission of Ultibro Breezhaler in China later this year.
"This is the second time Ultibro Breezhaler has shown superiority in improving lung function to Seretide in a head-to-head study and confirms benefits beyond this current standard of care," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "Such promising data will be part of a regulatory submission in China later this year and is exciting news for the COPD community and ultimately patients."
The LANTERN study also showed superiority of Ultibro Breezhaler compared to SFC for the key secondary objective of lung function (FEV1 AUC0-4h) over the first four hours post dose at week 26. The safety and tolerability profile of Ultibro Breezhaler was comparable to SFC.
COPD is a major public health concern in China, ranking first in terms of the country's disease burden. Recent estimates suggest that in China over 40 million people have COPD and the overall prevalence in people aged 40 years or older is 8%.
COPD symptoms can have a major, negative impact on a patient's ability to breathe and function and they reduce their quality of life. Essential daily activities such as climbing stairs can become very difficult as the condition gradually worsens. There is a need for new treatment options in COPD because many patients remain symptomatic despite medical therapy.
LANTERN was a randomized, double-blind, parallel-group, 26-week study conducted at 56 sites across China, Argentina, Chile and Taiwan. The study randomized 741 patients to assess the efficacy and safety of Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg compared to SFC 50/500 mcg in patients with moderate-to-severe COPD, with or without exacerbations in the previous year.
ILLUMINATE was the first study to demonstrate that Ultibro Breezhaler achieved superior lung function in patients with moderate-to-severe COPD and no history of exacerbations in the previous year, compared with twice-daily salmeterol/fluticasone 50/500 mcg administered with the Accuhaler dry powder inhaler.
Ultibro Breezhaler (indacaterol/glycopyrronium bromide) is a novel, once-daily dual bronchodilator approved in the EU as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Clinical trials have shown that Ultibro Breezhaler offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including SFC 50/500 mcg, in patients with no history of moderate or severe exacerbations over the last year and open-label tiotropium (18 mcg). Ultibro Breezhaler is currently approved for use in over 30 countries, including the EU, Japan, Canada and Australia.