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FDA Ad Com thumbs down on mortality benefit claim for Glaxo’s Trelegy Ellipta

August 31, 2020

The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 14-1 that the results from the IMPACT study evaluating GlaxoSmithKline’s (GSK +0.2%) Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder oral inhalation) in chronic obstructive pulmonary disease (COPD) patients do not provide sufficient evidence to support the proposed claim of a reduction in all-cause mortality.

The FDA approved the product in September 2017 for COPD.

Meeting materials

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