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Novartis submits COPD drug for EU approval

Pharmaceutical company Novartis has submitted an investigational chronic obstructive pulmonary disease therapy for marketing authorisation in the EU following positive phase III trial data

Switzerland-based pharmaceutical company Novartis has submitted an investigational chronic obstructive pulmonary disease (COPD) for marketing authorisation in the EU following a positive phase III trial.

The drug, to be marketed as Seebri Breezhaler (glycopyrronium bromide) if approved, is intended to help people with COPD live more active and productive lives.

The study data supporting the application demonstrated that the drug significantly increased patients' lung function compared to placebo and extended the time before COPD exacerbation – a worsening of the condition's symptoms.

A significant improvement in exercise endurance of COPD patients taking Seebri Breezhaler compared to placebo was also recorded. The number of COPD-related hospitalisations decreased in patients taking the drug was down too.

These data was presented at the European Respiratory Society (ERS) congress in Amsterdam.

Glycopyrronium bromide was licensed to Novartis in April 2005 by Vectura and its development partner Sosei.

27th September 2011

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