FDA’s review of GlaxoSmithKline PLC’s chronic obstructive pulmonary disease drug Breo Ellipta (fluticasone furoate/vilanterol dry powder inhaler) shows the agency and its outside advisors are willing to overlook statistical shortfalls in pivotal trials if they can be persuaded that a clinically meaningful benefit exists.
The agency called on its Pulmonary-Allergy Drugs Advisory Committee April 17 to review the efficacy and safety of Breo Ellipta...
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