EC approves Ultibro for COPD
The European Commission approved Ultibro Breezhaler indacaterol/glycopyrronium from Novartis AG (NYSE:NVS; SIX:NOVN) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). The approval triggered $10 million milestone payments to Vectura Group plc (LSE:VEC) and Sosei Group Corp. (Tokyo:4565) from the pharma under a 2005 deal. Novartis said Ultibro Breezhaler will be available in selected EU markets by year end.
Last week, Japan's Ministry of Health, Labor and Welfare (MHLW) approved the product for 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), delivered via the Breezhaler device (see BioCentury Extra, Sept. 20). ...