GSK’s Breo Ellipta Marches Forward For Asthma, Efficacy Undistinguished From Advair
This article was originally published in The Pink Sheet Daily
Follow-on may continue to face adoption challenges with expanded indication despite dosing convenience.
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After successful advisory panel – at least for adult asthma indication – Breo Ellipta seems headed for an expanded label, but GSK is still struggling to find some clinical differentiation from its aging twice-daily Advair.
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.
LABA safety issues may come to haunt GlaxoSmithKline as FDA’s Pulmonary-Allergy Drugs and Drug Safety and Risk Management advisory committees will focus on the combination’s product’s safety database and whether an outcomes study is needed for approval in asthma.