EU approves Novartis’ treatment for “smokers’ cough”

Hannah Blake

pharmaphorum

The European Commission has approved Novartis’ Seebri Breezhaler to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). This follows last week’s approval of Seebri Inhalation Capsules 50mcg in Japan.

COPD is an umbrella term for people with chronic bronchitis, emphysema, or both. It is commonly known as “smokers’ cough”, because the symptoms include breathlessness and coughing. It’s estimated that approximately three million people in the UK have COPD.

Seebri Breezhaler (glycopyrronium bromide) 44 mcg delivered dose, is a once-daily inhaled maintenance bronchodilator treatment. The European Commission has approved this treatment based on data from Phase 3 clinical trials, called GLOW, which tested the safety and efficacy of glycopyrronium bromide 44 mcg. The trials involved 1,996 COPD patients who required maintenance treatment and were from around the world, although many were from EU countries.

"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. 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.”

David Epstein, Division Head of Novartis Pharmaceuticals.

The GLOW clinical trials showed that glycopyrronium, when compared to placebo, significantly improved lung function over the first four hours after morning dosing. The trials also found 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.