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FDA Approves New Combination Drug for COPD — Physician’s First Watch

Medical News |
May 13, 2013

FDA Approves New Combination Drug for COPD

By Kristin J. Kelley

The FDA has approved a new dry powder inhaler (marketed as Breo Ellipta) to increase airflow and reduce exacerbations in patients with chronic obstructive pulmonary disease. The once-daily maintenance therapy combines the inhaled corticosteroid fluticasone furoate with vilanterol, a long-acting β2-adrenergic agonist (LABA).

In a study of 7700 patients with COPD, those treated with the combination drug had improved lung function and reduced exacerbations, compared with those on placebo.

Like other LABA-containing drugs, Breo Ellipta will carry a boxed warning about the increased risk for asthma-related death (it is not approved for asthma). Additionally, the drug is not recommended for patients younger than 18 years or for use as a rescue therapy for acute bronchospasm. Headache, nasopharyngitis, thrush, and upper respiratory tract infection are the most common side effects; the drug also increases the risks for both bone fractures and pneumonia.

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