Novartis Wins FDA OK of Low-Dose COPD Therapy

July 05, 2011

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).

"With millions of Americans known to be affected by COPD, the approval of Arcapta is good news for patients," says John W. Walsh, president and co-founder of the COPD Foundation. "A new once-daily medicine is a welcome addition to the treatment options for people suffering with this serious and debilitating disease."

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.

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.

Read the Novartis press release.