FDA advisers says data does not show safety of Glaxo inhaler for adolescents with asthma

MarketsAssociated Press

Government health advisers say a once-a-day respiratory inhaler from GlaxoSmithKline appears safe and effective for adults with asthma, but not for adolescents.

The Food and Drug Administration panel of experts voted 18-2 against using the British drugmaker's Breo Ellipta in asthma patients ages 12 to 17. That followed a positive vote of 16-4 supporting the drug's use in asthma patients 18 and up.

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The FDA is not required to follow the recommendations of its experts, though it often does.

Breo Ellipta is already approved in the U.S. for a type of chronic lung disease, but Glaxo is hoping to expand the drug's use to the much larger patient population of roughly 37 million Americans with asthma.