Swiss drugmaker Novartis has announced that once-daily dual bronchodilator, Ultibro Breezhaler (QVA149), has achieved positive CHMP opinion for the treatment of chronic obstructive pulmonary disease (COPD).
Ultibro Breezhaler was developed under the name of QVA149 (indacaterol/glycopyrronium), which is an investigational fixed-dose combination of both a long-acting beta2-adrenergic agonist (LABA), indacaterol, and a long-acting muscarinic antagonist (LAMA) glycopyrronium.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion based on Phase III IGNITE data of QVA149 that demonstrated to reduce rates of COPD exacerbations compared to open-label tiotropium 18mcg and glycopyrronium 50mcg.
The study in patients treated with QVA149 was designed to investigate the efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, shortness of breath and quality of life.
The recommendations of the CHMP will subsequently lead to granting of marketing authorization by the European Commission within the next three months.
Currently, worldwide submissions and reviews of QVA149 are ongoing, whereas the US filing is expected at the end of 2014.