BETHESDA, MD 05 July 2011—FDA and Novartis on Friday announced the approval of indacaterol, a long-acting beta2-adrenergic agonist (LABA), for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Indacaterol is the first drug in its class to be approved for once-daily use in patients with COPD, according to Novartis. The U.S. launch of the new product, dubbed the Arcapta Neohaler, is expected during the first quarter of 2012, the company stated.
According to the FDA-approved labeling (PDF) for indacaterol, the drug is indicated for long-term maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis or emphysema.
Indicaterol is not indicated for the treatment of asthma or acute deteriorations of COPD.
The drug's labeling includes a boxed warning about LABAs increasing the risk of asthma-related death in patients with asthma. The Contraindications section states that people with asthma may use an LABA only if they are taking other medications that provide long-term control of asthma.
In clinical trials, the most common adverse events associated with the use of indacaterol were runny nose, cough, sore throat, headache, and nausea.
An episode of coughing soon after inhalation of the drug was observed in about a quarter of clinical trial participants during at least 20% of visits to study clinics. According to the labeling, the cough generally occurred within 15 seconds after inhaling 75 µg of indacaterol, lasted no more than 15 seconds, and was not associated with bronchospasm, COPD exacerbation or deterioriation, or reduced drug efficacy.
The labeling for indacaterol includes a medication guide that describes the potential risks of the drug and provides instructions for the proper use of the Neohaler device.
The recommended dosage of indacaterol is one 75-µg capsule per day administered using the Neohaler.
Indicaterol inhalation powder will be sold as a 30-day supply consisting of 75-µg capsules packaged in blister packs of six capsules each with five blister packs per box. The packaging includes one Neohaler and the indacaterol medication guide.
The product should be stored at 77 °C, and the capsules should remain in their blister packs until immediately before use.