No drug has shown to improve all-cause mortality in patients with chronic obstructive pulmonary disease — a fact that led the FDA to pen a warning letter to AstraZeneca for its advertising of its COPD drug Breztri Aerosphere.
The FDA's Office of Prescription Drug Promotion reviewed promotional material about the drug and said it misrepresented its efficacy. The material stated Breztri Aerosphere saw a "difference observed in time to all-cause mortality (over 52 weeks)," but the FDA said this is misleading since no COPD medications have proven a positive result on all-cause mortality.
This misbranding is in violation of the Federal Food, Drug, and Cosmetic Act and "makes its distribution violative," the warning letter said. The letter is dated Aug. 4 and was posted to the agency's website on Aug. 15.