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GSK’s Breo Ellipta: FDA Panel To Weigh Large Safety Study For Asthma Claim

 
• By Sarah Karlin-Smith

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.

The adequacy of GlaxoSmithKline PLC’s Breo Ellipta safety database, particularly whether a large safety trial is needed to evaluate serious asthma outcomes, will be the focus of an FDA advisory committee’s March 19 review of a new asthma indication.

At a joint meeting, FDA’s Pulmonary-Allergy Drugs and Drug Safety and Risk Management advisory committees will also review the efficacy...

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