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Novartis AG's First-in-class Once-daily Dual Bronchodilator Ultibro Breezhaler (QVA149) Achieves Near Simultaneous Approval For COPD Patients In Europe And Japan


Monday, 23 Sep 2013 01:16am EDT 

Novartis AG 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 QVA149. The approvals of QVA149 in Europe and Japan were based on the comprehensive IGNITE Phase III clinical trial program, one of the international trial programs in COPD comprising 11 studies in total with more than 10,000 patients from 52 countries. 

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