Novartis won FDA approval for the Arcapta Neohaler that delivers indacaterol inhalation powder, a ?2-adrenergic agonist, in 75 mcg doses for patients with chronic obstructive pulmonary disease (COPD). It is indicated to be used once daily for long-term maintenance of chronic bronchitis and emphysema, something it had approval for in Europe for nearly two years now under the same trade name.
More from the announcement:
Arcapta 75 mcg was studied in a total of 641 COPD patients in two key Phase III 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 five minutes after the first dose and consistently maintained over 12 weeks. Arcapta also significantly reduced the need for patients to use daily rescue medication. Additionally, Arcapta improved health-related quality of life compared to placebo, as measured with 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.
The clinical trial program supporting US submission evaluated safety in 2,516 patients who received Arcapta for at least 12 weeks at doses of 75 mcg or more, with results supporting the safety and tolerability profile of Arcapta. The most common adverse reactions in 449 patients taking Arcapta 75 mcg (i.e. those reported in more than 2% of patients and with higher incidence than placebo) were cough, nasopharyngitis, headache, nausea and oropharyngeal pain.
