FDA panel backs Glaxo asthma drug for adults, not adolescents

March 19, 2015 8:58 PM

5 0

FDA panel backs Glaxo asthma drug for adults, not adolescents

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

Read more

To category page

Loading...