Thursday, April 26, 2012

Sosei - QVA149 superior to Advair in COPD patients

In The ILLUMINATE study once daily LABA/LAMA combination QVA149 (NVA237+QAB149 FDC) demonstrated superior  lung function (measured by FEV1 AUC0-12h with a p value <0.001) versus twice daily LABA/corticosteroid combination Advair (Salmetorol/Fluticasone). The ILLUMINATE study was a 26-week study and enrolled 523  moderate to severe COPD patients.

The data would support filing in EU, while the US filing would happen by YE 2014, as there is agreement now with the USFDA and Novartis on the clinical trial design of QVA149 and NVA237. NVA237 would be filed in US in early 2014.