EU and Japan approve Ultibro Breezhaler for COPD

Novartis has announced 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). In addition, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved once-daily Ultibro Inhalation Capsules (glycopyrronium 50 mcg / indacaterol 110 mcg), delivered through the Breezhaler device, for relief of various symptoms due to airway obstruction in Chronic Obstructive Pulmonary Disease (COPD). Ultibro Breezhaler / Ultibro Inhalation Capsules were developed under the name QVA 149.

The approvals of QVA 149 in Europe and Japan were 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 countries. From the eight IGNITE studies which completed in 2012, data showed that QVA 149 significantly improved lung function versus several current standard treatments and showed significant symptomatic improvements versus placebo in breathlessness, exercise tolerance, rescue medication use and health-related quality of life. QVA 149 also demonstrated statistically significant symptomatic improvements in breathlessness, rescue medication use and health-related quality of life compared to open-label (OL) tiotropium 18 mcg. The rate of all COPD exacerbations (mild, moderate and severe) was significantly improved with QVA 149 compared to glycopyrronium 50 mcg and OL tiotropium 18 mcg.