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FDA approves 24-hour COPD drug

May 13, 2013
by Pamela Tabar, Senior Editor
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The U.S. Food and Drug Administration (FDA) has given the green light to a new drug for chronic obstructive pulmonary disease (COPD). Breo Ellipta, co-developed by GlaxoSmithKline and Theravance, is being marketed as the first 24-hour maintenance inhalant for COPD.

The new drug is a combination of two other GlaxoSmithKline treatments: an inhaled corticosteroid (fluticasone furoate; on the market as Avamys/Veramyst) and vilanterol, a long-acting beta2-adrenergic agonist.

The drug has not been approved as an asthma treatment, and the packaging will carry warning labels noting that it should not be used as a rescue inhalant, notes the FDA release. Seniors taking the drug should be monitored carefully, since possible side effects also include increased risk of pneumonia and bone fractures.

The drug is one of several new compounds that could eventually replace GlaxoSmithKline’s Advair, which is seeing growing competition from generic products, reports Fox Business News.

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