The European Commission has approved Novartis’ Seebri Breezhaler (glycopyrronium bromide) 44µg delivered dose, as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
"The approval of Seebri Breezhaler in the European Union is an exciting and critical milestone that provides physicians and patients with a new once-daily COPD therapy so they have the flexibility of having the right treatment for the right patient at the right time," said David Epstein, division head of Novartis Pharmaceuticals. "We are proud that Novartis can deliver on our commitment to COPD patients and physicians by being the first company to offer two once-daily monotherapy bronchodilators with different modes of action, both delivered using Breezhaler devices."
The E.C. approved Seebri Breezhaler based on data from the Novartis phase III GLOW trials which demonstrated the safety and efficacy of glycopyrronium 44µg and involved 1,996 COPD patients who required maintenance treatment from around the world, with many in E.U. countries. The GLOW trials showed that glycopyrronium, when compared to placebo, significantly improved lung function over the first four hours after morning dosing and that this benefit was sustained for 24 hours over a 52-week period. Patients on glycopyrronium demonstrated improved lung function, reduced shortness of breath, reduced exacerbations, reduced use of rescue medication, improved quality of life and improved exercise tolerance compared to placebo.
Seebri Breezhaler is a long-acting muscarinic antagonist (LAMA), a type of bronchodilator that is recommended in COPD global treatment strategies as maintenance therapy.
Novartis is currently developing a fixed-dose combination of glycopyrronium and indacaterol, QVA149, which is expected to be filed in the E.U. and Japan by the end of 2012.