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Biotech / Medical : After Glaxo's genital herpes vaccine flop, check out Agenus
GSK 46.86-0.2%Oct 31 9:30 AM EST

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To: robert b furman who wrote (21)5/1/2015 5:17:58 AM
From: robert b furman   of 22
 
GSK making some excellent inroads to struggling N America market:

U.S. FDA approves Glaxo, Theravance's Breo Ellipta asthma drug


11 hours ago


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April 30 (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. It voted 19-1 that available data did not support approval for use in children aged 12 to 17.
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