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.
You may also be interested in...
GSK Gets New Start For Breo With FDA Approval In Asthma
FDA approved Breo Ellipta as a once-daily treatment for asthma, a new indication for a drug that has been on the market since October 2013 for COPD.
Asthma Warnings Not Working Well, FDA Fears As GSK Seeks Expanded LABA Approval
LABA prescribing patterns haven’t changed despite FDA’s labeling instructions on asthma safety concerns, agency concludes.
FDA/IoM “Uncertainty” Conference Adds Uncertainty to Biogen Growth Plans For Tysabri
An FDA/Institute of Medicine workshop on characterizing and communicating the uncertainty inherent in risk/benefit decisions touched on an important topic for every sponsor. But two “case studies” included points a very particular interest to Biogen Idec, and to sponsors in the COPD class.