Thursday, Novartis AG ADS (NVS), a Swiss drug maker, said that the European Commission or EC has approved its lead compound Onbrez Breezhaler in both 150 mcg and 300 mcg doses as a new once-daily maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease or COPD.
COPD is a progressive, life-threatening respiratory disease caused by cigarette smoke and other harmful fumes, and is characterized by a persistent obstruction of airflow in the lungs, resulting in chronic breathlessness.
Basel, Switzerland headquartered Novartis said that the EC based its approval on data from the pivotal Phase III results covering over 6,000 patients, which showed Onbrez Breezhaler significantly improved lung function and provided clinically relevant improvement in symptoms of breathlessness compared to tiotropium.
The data presented at the American College of Chest Physicians Chest Conference showed that once-daily Onbrez Breezhaler achieved improvements in lung function compared to twice-daily salmeterol, another current treatment option. In addition, Onbrez Breezhaler provided better health status and improved breathlessness compared with salmeterol.
Joe Jimenez, chief executive officer of the Novartis Pharmaceuticals Division said, "Onbrez Breezhaler has demonstrated greater improvements in lung function, breathlessness and quality of life compared to current therapies."
Novartis said, Onbrez Breezhaler, containing the active ingredient indacaterol maleate, is the first new inhaled compound for the treatment of COPD to be made available for EU patients in seven years. Additionally, it is the first and only treatment to demonstrate in clinical studies both 24-hour bronchodilation and a rapid onset of action within five minutes of inhalation.
Onbrez Breezhaler was filed with the United States Food and Drug Administration or FDA in late 2008. In October 2009, the company received a Complete Response letter from the US. The FDA requested additional information on the dosing proposed, which Novartis is working to address.
Novartis said it has three additional investigational treatments in its late-stage COPD portfolio. Novartis is also exploring new pathways in the treatment of COPD as part of an innovative, early-stage pipeline with disease modifying potential.
The company said COPD affects 210 million people globally, up to 82 million in Europe, and is projected to become the third leading cause of death worldwide COPD currently ranks tenth in overall disease burden, ahead of asthma and diabetes.
NVS closed Wednesday's regular trading at $55.77.
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