FDA advisory committee majority favored approval of GlaxoSmithKline’s fluticasone furoate/vilanterol combination for COPD despite the failure, under a prespecified statistical analysis plan, to demonstrate significant results on all primary endpoints. GSK is developing the drug with Theravance.
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...
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.
