Novartis (NYSE:NVS) said Tuesday that it has applied to start selling its treatment for chronic obstructive pulmonary disease -- typically associated with smokers cough and the elderly -- after a late-stage study showed it significantly improved patients lung function.
The investigational drug, called NVA237, would help patients with the disease maintain more active and productive lives, while also improving exercise endurance, Novartis said.
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The once-a-day drug has been submitted for approval in the European Union under the brand name Seebri Breezhaler, and Novartis is hoping for approval in 2012.
Of the more than 12 million people currently diagnosed with COPD, a disease associated with smoking, occupational exposure and air pollution, Novartis estimated that 50% of patients are below the age of 65, at the peak of their earning power and family responsibilities. The rest are elderly.
"These results provide important new insights into the potential effects of NVA237 in improving lung function and relieving symptoms such as breathlessness," said Dr Kai-Michael Beeh, the principal investigator of the GLOW3 study. "The improvements in exercise endurance are significant as exercise limitation is a considerable burden for COPD patients, affecting everyday activities such as climbing the stairs."
The NVA237 study, presented at the ERS congress in Amsterdam, also demonstrated a prolonged time before COPD exacerbated compared with placebo, and reduced hospitalizations.
Improvement in breathlessness was seen at 26 weeks, and Novartis said the drug showed stronger health-related quality of life and a reduction in the use of rescue medication.