Breo Ellipta, a respiratory medicine for COPD, failed to show any safety concerns when used to treat asthma per a preliminary FDA review but faces added scrutiny to assess its safety.
Breo now faces detailed scrutiny from FDA advisors over its safety in treating asthma and its suitability for children. The review meeting for the label expansion approval for the drug’s use in asthma patients 12 and older is due to be held in two days’ time. The company expects the final decision to be announced as soon as April 30.
