Letter to FDA opposing approval of fluticasone furoate/vilanterol (FF/VI) for COPD

View as PDF.

These comments are being submitted in follow-up to Public Citizen’s testimony presented at the April 17, 2013, meeting of the FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) opposing approval of the combination drug fluticasone furoate/vilanterol (FF/VI; proposed trade name Breo Ellipta). This combination offers no clinically meaningful benefit but clearly causes increased risks compared with the bronchodilator vilanterol alone. In addition, two of the four pivotal trials upon which this new drug application is based were unethical, withholding critical, long-acting bronchodilator therapy from patients in the placebo and inhaled corticosteroid arms.

May 2, 2013: Response letter from the Center for Drug Evaluation and Research