Novartis seeks approval of QVA149 in Japan

Novartis AG (NYSE:NVS; SIX:NOVN) submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) for QVA149 to treat chronic obstructive pulmonary disease (COPD). QVA149 is a fixed-dose combination of glycopyrronium bromide ( NVA237), an inhaled long-acting muscarinic receptor antagonist (LAMA), and indacaterol, a long-acting adrenergic receptor beta 2 agonist (LABA). Novartis has worldwide rights to develop and commercialize NVA237 from Sosei Group Corp. (Tokyo:4565) and Vectura Group plc (LSE:VEC) under a 2005 deal.

Last month, Novartis submitted a regulatory application for QVA149 for COPD in Europe. The pharma plans to submit a regulatory application for the product to FDA by year end 2014. NVA237 was approved in Europe in October as Seebri and in Japan in September as Seebri Breezhaler for COPD. Novartis markets indacaterol for COPD in more than 60 countries, including the U.S. and those of the EU. ...