FDA approves Glaxo, Theravance's Breo Ellipta asthma drug

April 30, 2015 9:33 PM

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FDA approves Glaxo, Theravance's Breo Ellipta asthma drug

(Reuters) - The U.S. Food and Drug Administration on Thursday approved the sale of Breo Ellipta as a once-daily treatment for asthma in patients aged 18 and older, GlaxoSmithKline and Theravance Inc said.

The FDA declined to approve Breo for younger asthma sufferers. The agency, in a so-called complete response letter, told the companies that additional data would be required to further demonstrate Breo's safety and efficacy in that population.

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