Swiss drug maker Novartis (NYSE: NVS) said results from its phase three study of experimental drug NVA237 remarkably improved lung function in patients with a life-threatening respiratory disease, in a similar way to rival drug Tiotropium.
A late stage study, named GLOW2, showed once daily use of NVA237, glycopyrronium bromide, improved lung function in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) compared with placebo, Novartis said in a statement.
According to the results, when compared to competitor drug tiotropium made by German-based Boehringer Ingelheim Pharmaceuticals, NVA237 displayed similar improvements in lung function in COPD patients.
"NVA237 has demonstrated its potential benefit for COPD patients in two large pivotal phase three studies,” said Novartis Pharmaceuticals Development global head, Trevor Mundel.
"This new study adds to the growing evidence that NVA237 could be an important treatment option for COPD, and supports our plans to develop a fixed-dose combination with our long-acting beta2-agonist Onbrez Breezhaler," added Mundel.
The study also found that the drug was well-tolerated with a similar incidence of adverse events for patients treated with NVA237, placebo and open-label tiotropium.
GLOW2, which took place over a 52 week period, was a double-blind and placebo controlled study involving 1,066 patients to assess the efficacy, safety and tolerability of the drug in patients with COPD.
Novartis said further efficacy and safety results from the study will be presented at a scientific congress in 2012, and the data will be used to support an application for regulatory approval, to be filed before the end of this year.
NVA237 was licensed to Novartis in April 2005 by Vectura and co-development partner Sosei.
COPD is a respiratory illness characterized by shortness of breath, coughing, wheezing and increased mucus production as a result of blockages in airflow in the lungs. More than 210 million people worldwide are affected by the disease, which is projected to be the third leading cause of death by 2020.
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