European Commission ( EC ) has approved Seebri Breezhaler ( Glycopyrronium bromide ) 44 mcg delivered dose ( equivalent to 50 mcg Glycopyrronium measured dose per capsule ), as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease ( COPD ).

The European Commission approved Seebri Breezhaler based on data from the phase III GLOW trials which demonstrated the safety and efficacy of Glycopyrronium 44 mcg and involved 1,996 COPD patients who required maintenance treatment.

The GLOW trials showed that Glycopyrronium, when compared to placebo, significantly has 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.

GLOW1 was a 26-week, randomized, double-blind, placebo-controlled study. The study demonstrated the clinically significant superiority of Glycopyrronium versus placebo for lung function improvements at 12 weeks ( primary endpoint ) measured by trough FEV1 ( p less than 0.01 ).

GLOW2 has demonstrated a similar magnitude of effect and also showed that Glycopyrronium was similar to open-label ( OL ) Tiotropium over 52 weeks measured by improvements in trough FEV1 compared to placebo.
In addition to demonstrating benefits in terms of lung function, Glycopyrronium exhibited a rapid onset of action within five minutes at first dose and reduced exacerbations.
Significant benefits in both breathlessness and health-related quality of life ( HRQL ), as measured by the Transition Dyspnea Index ( TDI ) and St. George's Respiratory Questionnaire ( SGRQ ) compared to placebo, were also demonstrated.
GLOW2 was a 52-week, randomized, double-blind, placebo-controlled study with OL Tiotropium 18 mcg as an active exploratory arm.

The GLOW3 study has showed that after Glycopyrronium was administered in the morning, patients experienced improved exercise tolerance from the first dose onward.
Overall, patients treated with Glycopyrronium experienced a significant 21% improvement in exercise endurance versus placebo at the end of the study ( day 21 ), with a significant 10% increase from day one ( both p less than 0.001 ).

In all studies, Glycopyrronium was shown to have an overall safety profile similar to placebo.

Source: Novartis, 2012

XagenaMedicine2012