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Reopening The LABA Class: FDA Shepherds Breo Through Committee For Asthma

This article was originally published in RPM Report

Executive Summary

A “safety focused” advisory committee is never something a sponsor looks forward to. But in the case of FDA’s review of GSK’s new Breo Ellipta asthma inhaler, the outcome was generally positive. In this case, FDA seems more concerned that too much emphasis on safety is steering development aware from an area of significant medical need.

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