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.”
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and networking platform access.
Already have an account? Log in
Already have an account? Log in
To submit a correction request, please visit our Contact Us page.
STAT encourages you to share your voice. We welcome your commentary, criticism, and expertise on our subscriber-only platform, STAT+ Connect