Testimony Before a Joint Meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Fluticasone Furoate/Vilanterol (Breo Ellipta) for Asthma

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The FDA should not approve the combination therapy, fluticasone furoate/vilanterol (Breo Ellipta) for the treatment of asthma, because the combination medicine may be dangerous in adolescents and little is known about its safety in adults. Breo Ellipta should not be approved for asthma until a large, adequately designed clinical trial is completed demonstrating that the combination therapy is as safe as the single ingredient fluticasone furoate for both adult and adolescent patients.