Published May 17, 2012
A Novartis experimental lung drug to treat smokers' cough was superior to a placebo in improving lung function over a one-year period and had similar efficacy to a rival drug from Pfizer and Boehringer Ingelheim, the Swiss drugmaker said on Thursday.
The Phase III GLOW2 trial showed a 50 mcg once-daily dose of NVA237 improved lung function, symptom relief and quality of life over a one-year period in patients with chronic obstructive pulmonary disease (COPD), commonly referred to as smokers cough, compared with a placebo.
The drug also showed similar efficacy to open-label tiotropium or Spiriva from Pfizer and Boehringer Ingelheim, in patients with moderate-to-severe COPD.
Novartis has carried out late-stage trials for NVA237, as it looks to tap into the lucrative market for respiratory drugs at a time when it is facing increasing competition for its top-selling products from generic rivals.
NVA327, or glycopyrronium bromide, was licensed to Novartis in 2005 by Vectura and its co-development partner Soseti.
Novartis submitted the drug for regulatory approval last year in Europe and Japan and expects to file the drug for U.S. regulatory approval at the start of 2014.
COPD causes breathing trouble and chronic coughing and it is sometimes fatal. An estimated 80 million people worldwide have moderate to severe COPD, according to the World Health Organisation.
Novartis plans to present the data from the trial at the 2012 American Thoracic Society (ATS) International Conference from May 18-23 in San Francisco.