FDA approves only once-daily LABA for COPD

July 8, 2011

FDA has approved once-daily indacaterol inhalation powder (Arcapta Neohaler, Novartis) 75 µg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Arcapta is not indicated for acute deteriorations of COPD or to treat asthma.

FDA has approved once-daily indacaterol inhalation powder (Arcapta Neohaler, Novartis) 75 µg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Arcapta is not indicated for acute deteriorations of COPD or to treat asthma.

Arcapta, formerly known as QAB149, is the first once-daily therapy in the long-acting beta2-agonist (LABA) class to be approved in the United States for maintenance treatment of airflow obstruction in COPD patients.

“Additional treatment options for COPD are needed,” Novartis spokeswoman Christine Cascio told Formulary.

In the United States, this disease affects more than 12 million people, while another 12 million people likely have COPD but are undiagnosed. It is the third-leading cause of death in the United States and a major cause of serious long-term disability.

“Arcapta Neohaler is an important new maintenance treatment option for COPD patients,” Cascio said. “Arcapta is also approved with data demonstrating improvements in health-related quality of life, as measured by the St. George's Respiratory Questionnaire [SGRQ].”

The SGRQ is widely used in clinical trials to measure symptoms, activities, and impact of COPD on daily life as reported by patients.

Arcapta 75 µg was studied in a total of 641 COPD patients participating in 2 key phase 3 trials lasting 12 weeks. Results at week 12 showed that Arcapta significantly improved lung function at 24 hours compared to placebo. Lung function improvements were seen 5 minutes after the first dose and were consistently maintained over 12 weeks. Arcapta also significantly reduced the need for patients to use daily rescue medication.

The clinical trial program supporting U.S. submission evaluated safety in 2,516 patients who received Arcapta for at least 12 weeks at doses of 75 µg or more, with results supporting the safety and tolerability profile of Arcapta. The most common adverse reactions in 449 patients taking Arcapta 75 µg (i.e., those reported in more than 2% of patients and with higher incidence than placebo) were cough, nasopharyngitis, headache, nausea, and oropharyngeal pain.

Indacaterol was first approved in November 2009 in the European Union under the brand-name Onbrez Breezhaler. It is now approved in more than 60 countries for the treatment of COPD and is available in more than 30 countries, with additional planned launches throughout 2011. The Arcapta U.S. launch is planned for the first quarter of 2012.

LABAs increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including indacaterol, the active ingredient in Arcapta Neohaler. The safety and efficacy of Arcapta Neohaler in patients with asthma have not been established. Arcapta Neohaler is not indicated for the treatment of asthma.