FDA panel gives favorable vote to GSK, Theravance COPD drug

FDA advisory committee recommends approval for Breo Ellipta

LONDON — A Food and Drug Administration panel has recommended that the agency approve an experimental drug for chronic obstructive pulmonary disease made by GlaxoSmithKline and Theravance, the two companies said.

The FDA Pulmonary-Allergy Drugs Advisory Committee voted 9-4 to recommend Breo Ellipta as a long-term maintenance treatment for airflow obstruction in patients with COPD and for reduction of COPD exacerbations in patients with a history of them. The drug is a once-daily inhaler that combines fluticasone furoate and vilanterol.

The panel also voted that the safety of the drug had been adequately demonstrated.

An FDA advisory committee vote does not guarantee approval of a drug, and the agency is not required to follow its recommendation, but usually does.


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