First in class once-daily dual bronchodilator Ultibro Breezhaler (QVA149) approved for the treatment of COPD in Europe
Ultibro® Breezhaler® (QVA149) is the first once-daily dual bronchodilator to gain European Commission approval as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD
Pivotal Phase III IGNITE data showed QVA149 significantly improved lung function and patient-reported outcomes including breathlessness and rescue medication use, compared to current standards of care1-3
COPD is a progressive disease affecting up to 10% of adults across Europe4 and is projected to be the third leading cause of death by 20205
Tokyo, Japan – 23 September 2013: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the information released today by Novartis announcing that the European Commission approved once-daily Ultibro® Breezhaler® (indacaterol 85 mcg / glycopyrronium 43 mcg) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Ultibro® Breezhaler® was developed under the name QVA149. The approval triggers a $10m milestone payment to Sosei.
Dual bronchodilation with QVA149 is expected to set a new standard of care in COPD by combining the proven efficacy and safety benefits of two established Novartis COPD treatments, the LABA*, Onbrez® Breezhaler® (indacaterol), and the LAMA**, Seebri® Breezhaler® (glycopyrronium bromide). Both these components are delivered through the Breezhaler® inhalation device, as is QVA149, and are widely available in many countries around the world.
Last week, QVA149 was approved also in Japan and US submission is anticipated at the end of 2014.
The approval of QVA149 was based on the comprehensive IGNITE Phase III clinical trial program, one of the largest international trial programs in COPD comprising 11 studies in total with more than 10,000 patients from 52 countries1-3,6-15. From the eight IGNITE studies which completed in 20121-3, 6-10, data showed that QVA149 significantly improved lung function versus several current standard treatments1-3,6 and showed significant symptomatic improvements versus placebo in breathlessness, exercise tolerance, rescue medication use and health-related quality of life1,2,6. QVA149 also demonstrated statistically significant symptomatic improvements in breathlessness, rescue medication use and health-related quality of life compared to open-label (OL) tiotropium 18 mcg1. The rate of all COPD exacerbations (mild, moderate and severe) was significantly improved with QVA149 compared to glycopyrronium 50 mcg and OL tiotropium 18 mcg3.
In clinical studies, QVA149 demonstrated an acceptable safety profile with no meaningful differences between the treatment groups (placebo, indacaterol 150 mcg, glycopyrronium 50 mcg, OL tiotropium 18 mcg, salmeterol / fluticasone (SFC) 50 mcg / 500 mcg) in the incidence of adverse and serious adverse events1-3,6. The safety profile was characterized by typical anticholinergic and beta-adrenergic effects related to the individual components of the combination1-3,6-10.
Ultibro®, Seebri®, Onbrez® and Breezhaler® are registered trademarks of Novartis AG.
* a long-acting beta2-adrenergic agonist, ** a long-acting muscarinic antagonist
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