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Phase III Study Shows Once-Daily NVA237 is Superior to Placebo and Similar to Tiotropium in Improving Lung Function in COPD

Thu, 06/30/2011 - 2:33am
Bio-Medicine.Org

TOKYO, June 30, 2011 /PRNewswire/ --

  • GLOW2 Study Shows NVA237 Provides Superior24-hour Bronchodilation to Placebo (p<0.001) with Comparable Efficacy to Open-Label Tiotropium at 12 Weeks
  • NVA237 Shown to be Well-Tolerated in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
  • Phase III data Support First Regulatory Submission by Novartis for NVA237 by end of 2011

 

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), announces that results reported today by Novartis from the pivotal Phase III GLOW2 clinical trial show that once-daily NVA237 (glycopyrronium bromide) 50 mcg significantly improved lung function in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) relative to placebo (p<0.001), with similar efficacy to open-label tiotropium.

Further efficacy and safety results from GLOW2 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 2011.

Mr Shinichi Tamura, CEO of Sosei, said: "GLOW2 is the second NVA237 Phase III study to meet its primary end point and further endorses the benefit of NVA237 in COPD patients.  We look forward to Novartis filing the product in 2011, followed by the filing of QVA149, the fixed-dose combination of NVA237 and indacaterol, expected to occur in 2012 ."

In an exploratory arm of the study, NVA237 was compared with open-label tiotropium (Spiriva® HandiHaler[® Spiriva® and HandiHaler® are registered trademarks of Boehringer Ingelheim Pharma GmbH & Co. KG.]) 18 mcg, another once-daily long-acting muscarinic antagonist (LAMA) indicated for the treatment of COPD. Results show that NVA237 produced similar improvements in lung function to tiotropium.

The study met its

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