FDA Approves Once-Daily Bronchodilator for COPD

July 01, 2011

July 1, 2011 (UPDATED July 21, 2011) — The US Food and Drug Administration (FDA) approved a once-daily bronchodilator — indacaterol maleate (Arcapta Neohaler, Novartis Pharmaceuticals) — for chronic obstructive pulmonary disease (COPD). This bronchodilator may offer better patient adherence than twice-a-day bronchodilators on the market.

Indacaterol maleate is a new molecular entity in the β2-adrenergic agonist class that helps relax muscles around lung airways to prevent COPD symptoms, such as wheezing and breathlessness. The FDA stated that the long-acting drug is not intended to treat asthma or COPD symptoms that come on fast and strong.

Common adverse effects (> 2% and more common than placebo) are runny nose, cough, sore throat, headache, and nausea.

Indacaterol maleate will carry a boxed warning that, like other long-acting β2-adrenergic agonists (LABAs), may increase the risk for asthma-related death.

Without use of a long-term asthma control medication, indacaterol maleate and all LABAs are contraindicated in patients with asthma. Indacaterol maleate should not be started in patients with acutely deteriorating COPD, nor should it be used to relieve acute symptoms, which should be managed with concomitant short-acting β2-agonists.

An FDA advisory panel in March recommended approval of indacaterol maleate after 6 confirmatory clinical trials demonstrated the drug's safety and efficacy. The trials included nearly 5500 patients 40 years and older with COPD who had smoked at least 1 pack of cigarettes for 10 years and exhibited moderate to severe decreases in lung function.

During the advisory panel meeting, John Walsh, the president of the nonprofit COPD Foundation, said that getting patients to faithfully take twice-daily LABAs is a challenge.

"The advantage of a once-daily LABA to increase compliance and impact adherence cannot be overstated," Walsh said.

Administration and Precautions

Indacaterol maleate is supplied as 75-μg inhalation powder hard capsules that should always be used with the Neohaler inhaler only, 75 μg inhaled once daily every day. The capsules are for oral inhalation only and are not to be swallowed. The recommended dose should not be exceeded because excessive use of indacaterol maleate, or use in conjunction with other LABA-containing medications, may cause clinically significant cardiovascular effects and may even be fatal.

Should life-threatening paradoxic bronchospasm occur, use of indacaterol maleate should immediately be discontinued. The inhaler should be used with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, or sensitivity to sympathomimetic drugs.

Indacaterol maleate should be used with caution with other adrenergic drugs, as these may potentiate its effects. It should be used with caution with xanthine derivatives, steroids, diuretics, or non–potassium-sparing diuretics, as these medications may potentiate hypokalemia or electrocardiographic changes. Extreme caution is warranted when indacaterol maleate is used with monoamine oxidase inhibitors, tricyclic antidepressants, and drugs that prolong QTc interval, as these may potentiate cardiovascular effects. Because β-blockers may reduce the efficacy of indacaterol maleate, these should be used with caution and only when medically necessary.

Indacaterol maleate is pregnancy Category C, and it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because β-agonists may interfere with uterine contractility, indacaterol maleate should be used during labor only in those patients in whom the benefits clearly outweigh the risks. Caution is warranted when indacaterol maleate is administered to breast-feeding women.

The safety and efficacy of indacaterol maleate in pediatric patients have not been determined; therefore, the drug is not indicated for use in children. No adjustment of dosage is warranted in geriatric patients, based on available data, nor in patients with mild and moderate hepatic impairment. Studies were not performed in patients with severe hepatic impairment nor in those with renal impairment, but the urinary pathway contributes very little to total body elimination.

More information on the FDA's approval of indacaterol maleate is available on the agency's Web site.

Laurie Barclay, MD, contributed to the synopsis.


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