FDA's Advisory Committee to Review Claims That GlaxoSmithKline's Trelegy Ellipta Reduces Mortality

The Food and Drug Administration is asking one of its panels of outside experts to help it make a decision about GlaxoSmithKline's (NYSE: GSK) request to add data to the label of Trelegy Ellipta, its chronic obstructive pulmonary disease (COPD) drug. The pulmonary-allergy drugs advisory committee will meet on April 21 to discuss whether the claim that Trelegy Ellipta reduces mortality should be added to the drug's label. That would allow the company to use the information in its marketing materials.

Results from the Informing the Pathway of COPD Treatment (IMPACT) clinical trial showed that Trelegy Ellipta reduced the risk of on-treatment all-cause mortality by 42.1% compared to Anoro, which contains two of the three medications in Trelegy Ellipta.

But the FDA seems to be concerned that 70% of patients treated with Anoro in the study were taking inhaled corticosteroids beforehand, and had to go off of them during the trial, which might have affected the results. An editorial in the New England Journal of Medicine chastised the company for the trial's "design peculiarity."

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Source Fool.com