In its third quarter results for 2011, Novartis announced that, “In the US, NVA237 will require additional clinical data to support submission and thus will be delayed.” Furthermore, the company warned, “The changes to the US NVA237 program will similarly impact approval timing for QVA149 in the US where additional clinical studies will be required. The QVA149 submission remains on track for 2012 in EU and rest of world.”
Novartis filed an MAA for the NVA237 glycopyrronium bromide dry powder inhaler with the European Medicines Agency in September 2011. If approved, the product will be marketed as Seebri Breezhaler in Europe. QVA149 is a fixed-dose combination of NVA237 and indacaterol.
Read the Novartis Q3 results.
