Asthma Warnings Not Working Well, FDA Fears As GSK Seeks Expanded LABA Approval
This article was originally published in The Pink Sheet Daily
LABA prescribing patterns haven’t changed despite FDA’s labeling instructions on asthma safety concerns, agency concludes.
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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.
FDA advisory committee votes recommends Breo Ellipta for asthma in adults with post-approval safety study, but panel wants additional premarket efficacy and safety data for adolescents.
FDA’s Pulmonary-Allergy Drugs and Drug Safety and Risk Management advisors will cast separate votes March 19 on GSK’s ICS/LABA combo for patients 12-17 and for adults 18 and older.