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FDA approves Arcapta Neohaler, a once-a-day inhaler for long-term maintenance of COPD
MedScape
WASHINGTON — The US Food and Drug Administration (FDA) has approved a once-daily bronchodilator for chronic obstructive pulmonary disease (COPD) that promises better patient adherence than twice-a-day bronchodilators on the market.
The new drug is indacaterol maleate, which will be marketed by Novartis Pharmaceuticals as the Arcapta Neohaler. It is a long-acting beta2-agonist (LABA).
Most people with Alpha-1 Antitrypsin Deficiency are also diagnosed with COPD. The new drug is currently the only once-daily LABA approved by the FDA.
COPD affects more than 12 million people in the US, while another estimated 12 million people are believed to have the disease but remain undiagnosed, according to the National Heart, Lung and Blood Institute. It ranks as the third leading cause of death in the US and is a major cause of long-term disability.
An FDA advisory panel in March recommended approval of indacaterol maleate after six 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, president of the COPD Foundation and Alpha-1 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.
The FDA emphasized that the drug is not to be used to treat acute exacerbations, and 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.
