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news.Sosei Group said data from the Novartis' pivotal GLOW1 study evaluating NVA237 met its primary endpoint, when assessed as a once daily treatment for chronic obstructive pulmonary disease (COPD) and has demonstrated superior bronchodilation to placebo at 12 weeks measured by trough FEV1 (i.e. forced expiratory volume in one second), a standard measure of lung function.
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Novartis has been awarded NVA237’s license by Sosei and its co-development partner Vectura in April 2005.
Novartis plans to launch NVA237 as a once-daily monotherapy for COPD in 2012.
Novartis said the pivotal double-blind 26-week GLOW1 study of NVA237 has showed improvement in lung function and has also demonstrated a good safety profile in patients with moderate-to-severe COPD.
Sosei CEO Shinichi Tamura said they are very encouraged that results from the initial pivotal GLOW1 trial, showing significantly increased lung function with a positive safety profile, have provided further confirmation of the clinical potential of NVA237 as a novel once-daily LAMA therapy for COPD patients.