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

Markets Associated 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.

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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.

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.