New Inhaler Drug for COPD Approved
WASHINGTON -- A new beta2-adrenergic agonist drug, indacaterol inhalation powder (Arcapta Neohaler), has won FDA approval as long-term maintenance therapy for chronic obstructive pulmonary disease, the agency announced.
A product of Novartis, the drug was tested in six clinical trials with a total of nearly 5,500 current or former smokers 40 and older.
An FDA advisory committee voted 13-4 in March to recommend that the drug be approved , although only at the 75-mcg dosage. The panel recommended against approval of a 150-mcg dose, citing a lack of clear evidence that the higher dose was any more effective or that it was as safe as the lower dose.
Following the committee's recommendation, the FDA approved only the 75-mcg dose.
This was the second try by Novartis to win FDA approval for indacaterol. The agency had rejected the company's first application in 2009, which had sought approval for doses as high as 300 mcg.
Novartis conducted additional clinical studies at the 75- and 150-mcg doses to satisfy the FDA's concerns.
The agency emphasized that the drug is not to be used to treat acute exacerbations. It also should not be used by people with asthma unless they are also taking long-term controller medications such as inhaled corticosteroids.
Indacaterol will carry the same black-box warning as other long-acting beta agonists about increased risk of asthma-related death.
Side effects seen most commonly in the drug's clinical studies included runny nose, cough, sore throat, headache, and nausea, the FDA said.
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Obstructive Lung Disease - News
WASHINGTON -- A new beta2-adrenergic agonist drug, indacaterol inhalation powder (Arcapta Neohaler), has won FDA approval as long-term maintenance therapy for chronic obstructive pulmonary disease,
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