Novartis International AG (NVS) said results from the pivotal Phase III GLOW2 study demonstrated that once-daily 50 mcg NVA237 (glycopyrronium bromide) was superior to placebo in improving lung function, symptom relief and quality of life, and reducing exacerbations over a one-year period.
According to the company, GLOW2 met its primary endpoint by demonstrating NVA237 provided superior 24-hour bronchodilation compared to placebo at 12 weeks measured by mean trough FEV1.
The company also noted that NVA237 was submitted for EU approval under proposed brand name Seebri Breezhaler and it expects US filing in 2014.
"The GLOW2 results affirm the potential for once-daily NVA237 to help patients manage their COPD symptoms and improve their quality of life," said Tim Wright, Head of Development, Novartis Pharmaceuticals. "Novartis is committed to addressing the unmet needs of COPD patients by providing innovative medicines and devices, and the results of GLOW2 demonstrate that NVA237 could be the second innovative product in our COPD portfolio."
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