GSK, Theravance’s Breo Faces Scrutiny Over Safety for Asthma
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GlaxoSmithKline Plc and Theravance Inc.’s respiratory drug Breo Ellipta will face questions from a regulatory panel over the safety of expanding its use to treat asthma patients and whether it’s suitable for children.
Advisers to the U.S. Food and Drug Administration will meet Thursday to discuss whether Breo could actually exacerbate asthma symptoms and whether Glaxo’s database of clinical trial patients designed to examine safety concerns is adequate, according to documents released Tuesday by the FDA.