The Food and Drug Administration scolded AstraZeneca for making misleading claims about the effectiveness of a key medicine used treat chronic obstructive pulmonary disease.
In an Aug. 4 warning letter, the agency admonished the company for a promotional sales aid that suggested the treatment, called Breztri, had a positive impact on death rates and reduced the risk of death in COPD patients. But the suggestions were not supported by a clinical trial cited in the promotional material, according to the FDA.
“No conclusions about the effect of Breztri on all-cause mortality,” which refers to the rate of death due to any cause in a population, “can be drawn from the (clinical) trial,” the FDA wrote. The agency added that, “to date, no drug has been shown to improve all-cause mortality” in chronic obstructive pulmonary disease, or COPD. For these reasons, the promotional material was “concerning from a public health perspective.”