Novartis Submits NDA for Two New COPD Inhalation Therapies in China

Author: Baihuawen

On May 23, Novartis’ two new drug applications for COPD submitted in China were accepted by the CDE, namely indacaterol/glycopyrronium/mometasone furoate inhalation powder and indacaterol/mometasone furoate inhalation powder.

Indacaterol is a long-acting β2-adrenergic agonist (LABA), glycopyrronium bromide is a long-acting muscarinic antagonist (LAMA), and mometasone furoate is a glucocorticoid. Novartis has currently launched in China the LABA/LAMA dual-combination drug indacaterol/glycopyrronium powder for inhalation capsules (brand name: Ultibro), the LAMA drug glycopyrronium powder for inhalation capsules (brand name: Seebri), and the LABA drug indacaterol maleate powder for inhalation (brand name: Onbrez).

Chronic Obstructive Pulmonary Disease (COPD), commonly known as chronic bronchitis and emphysema, is a chronic inflammatory airway disease caused by inhalation of tobacco smoke, occupational dusts, or polluted air. Clinically, it is primarily characterized by progressively worsening dyspnea, with or without cough and sputum production. Pulmonary function tests reveal obstructive ventilatory impairment. Disease progression can easily lead to respiratory failure and cor pulmonale. Data show that the prevalence of COPD among individuals aged 20 years and older in China is 8.65%, and 13.7% among those aged 40 years and older, with an estimated nearly 100 million COPD patients nationwide.

Currently, two ICS/LAMA/LABA triple-combination therapies and three ICS/LABA dual-combination therapies have been approved for marketing in China.