Novartis receives EU approval for Seebri Breezhaler

Novartis has announced that its new inhaler-based chronic obstructive pulmonary disease (COPD) therapy Seebri Breezhaler has received European regulatory approval.

The European Commission has ratified the glycopyrronium bromide 44 mcg delivered dose as a once-daily inhaled maintenance bronchodilator treatment for relieving COPD symptoms among adult patients.

Data from the phase III Glow trials has demonstrated the safety and efficacy of the therapy, with the product proving able to significantly improve lung function over the first four hours after morning dosing, a benefit that was then sustained over a 52-week period.

David Epstein, division head of Novartis Pharmaceuticals, said: "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."

Last month, the company received recommendations from Europe's Committee for Medicinal Products for Human Use for approval of new indications for the diabetes therapies Galvus and Eucreas.