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FDA panel backs Glaxo asthma drug for adults, not adolescents

Reuters - UK Focus

March 19 (Reuters) - GlaxoSmithKline Plc (Other OTC: GLAXF - news) 's drug to treat chronic breathing problems is safe and effective enough to be approved in adults with asthma but not adolescents, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday.

The panel voted 16 to 4 that the product, Breo Ellipta, should be approved for once daily treatment of asthma in adults 18 years and older. It voted 19 to 1 that the data did not support approval for use in children aged 12 to 17.

The FDA is not obliged to follow the advice of its advisory panels but typically does so. Glaxo licensed the product from Theravance Inc (NasdaqGS: THRX - news) in 2002. (Reporting by Toni Clarke in Washington; Editing by Sandra Maler)