MHLW Committee Endorses QVA149's Approval To Treat COPD
On August 26, Sosei reported that the Drug Committee of Ministry of Health, Labour and Welfare (MHLW) in Japan has endorsed approval of once daily QVA149 (glycopyrronium bromide+indacaterol), developed by Novartis, as a treatment to relieve symptoms due to airway obstruction in chronic obstructive pulmonary disease (COPD) in Japan. The Japanese MHLW is expected to follow with
approval in due course.
The product combines two bronchodilators: glycopyrronium, a long-acting muscarinic antagonist; and indacaterol, a long-acting beta2-adrenergic agonist. In July, the EMA's CHMP adopted a positive opinion for the approval of QVA149 in Europe under the brandname, Ultibro Breezhaler. Ultibro and Breezhaler are registered trademarks of Novartis.