AstraZeneca lands OPDP untitled letter over Farxiga TV ad
The US Food and Drug Administration (FDA) on Monday published an untitled letter it sent to AstraZeneca on 23 September concerning a TV commercial for its drug Farxiga (dapagliflozin). Regulators claimed that the company failed to fully disclose the endpoints used to approve the drug in the 45-second ad.The letter, sent by FDA’s Office of Prescription Drug Promotion (OPDP), noted that the British-Swedish drugmaker aired an ad that only mentions the drug is intended to reduce the risk of cardiovascular death, failing to capture the specifics of the endpoint used to approve the drug. The drug is used to treat type 2 diabetes, as well as heart failure and chronic kidney disease.
“The TV ad is misleading because it misleadingly represents that Farxiga was approved only on the single endpoint of ‘reducing the risk of cardiovascular death’ in adults with chronic kidney disease (CKD) or heart failure (HF) when this is not the case,” said FDA. “The approval of Farxiga in patients with CKD was based on the reduction in the incidence of the primary composite endpoint of ≥50% sustained estimated glomerular filtration rate (eGFR) decline, progression to end-stage kidney disease (ESKD), cardiovascular (CV) or renal death.
“Similarly, the approval of Farxiga in patients with HF was based on two trials that evaluated on the reduction of the incidence of the primary composite endpoint of CV death, hospitalization for HF or urgent HF visit,” the agency added.
FDA pointed out that the indications and usage section of Farxiga's label emphasizes that it is intended to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. It also states that it is intended to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure. None of which was made clear in the TV ad.
"By failing to adequately communicate all of the components that contribute to the indications for these respective populations, the TV ad creates a misleading impression about the FDA-approved indications for Farxiga in adults with CKD and HF," said FDA.
The untitled letter follows a surge in FDA enforcement activity related to prescription drug promotion that kicked off one week prior, in which the agency sent more than 100 warning and untitled letters to drugmakers. (RELATED: FDA posts more than 100 warning and untitled letters in ad crackdown, Regulatory Focus 16 September 2025)
OPDP gave AstraZeneca 15 days to respond to the untitled letter.
Untitled letter
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