Ultibro Breezhaler indacaterol/glycopyrronium bromide regulatory update

EMA's CHMP issued a positive opinion recommending approval of Ultibro Breezhaler (QVA149) from Novartis as a maintenance bronchodilator treatment to relieve symptoms in adult patients 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 to FDA by the end of 2014.

Novartis already markets the individual components of Ultibro Breezhaler in the EU. 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. ...