The U.S. Food and Drug Administration (FDA) has issued a warning letter to AstraZeneca for making false or misleading claims about Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate), its approved inhalation therapy for chronic obstructive pulmonary disease (COPD).
According to the FDA, promotional material about Breztri distributed by AstraZeneca includes claims about the therapy’s ability to lower a risk of death from any cause, and a risk of severe exacerbations among COPD patients. The claims are not supported by clinical evidence.
“These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the overall benefits a patient may expect as a result of Breztri treatment,” the FDA stated in its warning letter.
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AstraZeneca has 15 days to issue a response to the agency addressing these issues, listing all other promotional communications containing these types of claims, and outlining plans to discontinue use of such communications and provide “truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter.”
“Failure to adequately address this matter may lead to regulatory action,” the warning letter states.
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