GSK’s Breo Ellipta: FDA Panel To Weigh Large Safety Study For Asthma Claim
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
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.
GlaxoSmithKline’s all important asthma drug, Advair, has taken a hit and the impact is bleeding out to the rest of the business. As GSK braces for a challenging 2015, the company announced a £1 billion cost savings program and plans to explore an IPO for its HIV subsidiary ViiV Healthcare.
If cardiovascular studies are required for non-cardiac drugs, they should be focused on specific signals of heart-related concern that may not include ischemic events, advisory committee cardiologists say during review of Novo Nordisk’s Saxenda for obesity.