CHMP backs Novartis QVA149 for COPD

EMA's CHMP issued a positive opinion recommending approval of Ultibro Breezhaler ( QVA149) from Novartis AG (NYSE:NVS; SIX:NOVN) as a maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). The product 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 plans to submit a regulatory application for the product to FDA by the end of next year.

Novartis already markets the individual components of Ultibro Breezhaler in the EU and elsewhere. The pharma markets glycopyrronium bromide for COPD in Europe as Seebri Breezhaler, and in Japan, Canada and Australia. Novartis also markets indacaterol for COPD in about 100 countries, including the U.S. and in those of the EU, under the name Onbrez Breezhaler. ...