BASEL (dpa-AFX) - Novartis AG (NVS), Friday announced that the US Food and Drug Administration has approved once-daily Arcapta Neohaler (indacaterol inhalation powder) 75 mcg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease.
Novartis said the decision makes Arcapta, formerly known as QAB149, the first once-daily therapy in the long-acting beta(2)-agonist or LABA class to be approved in the US for maintenance treatment of airflow obstruction in Chronic Obstructive Pulmonary Disease patients. Arcapta is not indicated for acute deteriorations of COPD or to treat asthma.
Chronic Obstructive Pulmonary Disease or COPD is a chronic, progressive lung disease that is commonly caused by tobacco smoking, air pollution or occupational exposure, and results in airflow obstruction and debilitating bouts of breathlessness.
More than 12 million people in the US are affected, while another estimated 12 million people are believed to have the disease but remain undiagnosed. Novartis said COPD ranks as the third leading cause of death in the US and a major cause of serious long-term disability.
John Walsh, president and co-founder of the US-based COPD Foundation, said,' A new once-daily medicine is a welcome addition to the treatment options for people suffering with this serious and debilitating disease.'
In two key Phase III trials lasting 12 weeks, Arcapta improved lung function significantly at 24 hours compared to placebo. The improvements were seen five minutes after the first dose and were consistently maintained over 12 weeks.
Additionally, Arcapta improved health-related quality of life compared to placebo, as measured with the St George's Respiratory Questionnaire.
The U.S. submission was based on a clinical trial program which evaluated safety in 2,516 patients who received Arcapta for at least 12 weeks at doses of 75 mcg or more.
Earlier today, Basel, Switzerland-headquartered Novartis announced approval in Japan for Onbrez Inhalation Capsules (indacaterol) 150 mcg once-daily, for relief of symptoms due to airway obstruction in COPD.
Indacaterol was first approved in November 2009 in the European Union under the brand-name OnbrezBreezhaler.
The Arcapta US launch is planned for the first quarter of 2012.
NVS closed Friday's regular trading at $61.15, up $0.04 or 0.07%, on the NYSE.
Copyright RTT News/dpa-AFX