FDA approves Glaxo, Theravance's Breo Ellipta asthma drug

FDA approves Glaxo, Theravance's Breo Ellipta asthma drug

A jogger runs past a signage for pharmaceutical giant GlaxoSmithKline in London(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. The FDA’s decision came after an FDA advisory panel of experts had voted 16-4 that Breo Ellipta should be approved for use by adults.

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