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NVA237 meets primary endpoint in Phase 3 study

NVA237, a once daily, long acting muscarinic agent (LAMA) DPI for the treatment of COPD, met its primary endpoint of improved bronchodilation compared to placebo after 12 weeks. The glycopyrronium bromide dry powder formulation was licensed to Novartis by Sosei and Vectura in 2005.

Novartis announced the results in its first quarter 2011 earnings report, along with plans to present data from the study at a scientific meeting later in the year. According to its web site, the company plans to file an NDA for NVA237 by the end of 2011.

QVA149, a combination therapy of NVA237 and Novartis’s indacaterol, is scheduled to launch in 2013; however, the US FDA has yet to announce whether it will approve indacaterol.

Read Sosei press release.
Read Novartis first quarter report.

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published on April 19, 2011

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