FDA approves another drug for COPD

By Reuters Staff

(Reuters) - The U.S. Food and Drug Administration approved GlaxoSmithKline's new inhaled drug for chronic obstructive pulmonary disease (COPD).

The drug called Anoro Ellipta combines vilanterol, a long-acting beta-agonist (LABA) that opens the airways, and umeclidinium, a long-acting muscarinic receptor antagonist (LAMA) that improves lung function.

However, Anoro Ellipta will carry a warning that one of its components increase the risk of asthma-related death, the FDA said in a statement released on its website.

The warning on the drug's label is one of the strongest issued by the regulator and relates to the effect of LABA drugs on asthma patients.

An FDA advisory panel in September voted unanimously in favor of the drug's efficacy but had expressed concerns about its safety profile.

The panel highlighted imbalance in the number of non-fatal heart attacks experienced by patients on Anoro in certain trials, compared with a placebo.

Glaxo developed Anoro Ellipta with U.S. partner Theravance Inc.

Glaxo and Theravance received FDA approval for another COPD drug, Breo Ellipta, in May. Breo Ellipta, an inhaled combination of vilanterol and corticosteroid fluticasone furoate, was launched in October.

COPD is the third leading cause of death in the United States, according to federal data. The disease, mostly caused by cigarette smoking, can lead to coughing, wheezing, shortness of breath and tightness in the chest.

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