FDA issues warning to AstraZeneca over Breztri claims

Graphic of envelope with red warning triangle coming out of it.

The U.S. Food and Drug Administration has issued a warning letter to AstraZeneca Pharmaceuticals over claims the company has made about the efficacy of its Breztri Aerosphere inhaler treatment for COPD.

According to the letter, which was issued in early August, the company allegedly published false or misleading claims about Breztri in promotional materials with regard to the drug’s ability to reduce the risk of all-cause mortality(ACM)—that is, the risk of death as the result of any disease, complication, accident or exposure.

“These claims and presentation, in the context of a promotional communication describing the safety and efficacy of Breztri, are misleading because they suggest that Breztri treatment has been shown to have a positive impact on all-cause mortality and reduce the risk of death in COPD patients,” the letter states. “These suggestions are not supported by the cited references.”

The letter goes on to say that the clinical trial cited by AstraZeneca—the Efficacy and Safety of Triple Therapy in Obstructive Lung Disease—does not allow for any conclusions to be drawn from its data on all-cause mortality and that “no conclusions about the effect of Breztri on ACM can be drawn from the ETHOS trial.”

The FDA states that, to date, no drug has been shown to improve ACM in COPD patients.

“These claims and presentation are concerning from a public health perspective because they overstate the efficacy of the drug and misleadingly suggest that Breztri will have a positive impact on ACM and reduce the risk of death in COPD patients,” the letter said.

The letter also warned AstraZeneca over claims that Breztri will have a statistically significant reduction in severe exacerbations for COPD patients.

“This suggestion is not supported by the ETHOS trial data analyzed in the cited reference because the reduction in severe exacerbations was not statistically significant for patients treated with Breztri relative to comparator groups,” the letter stated. 

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