The FDA updated the indication and usage section of the dapagliflozin (Farxiga) label on 2026-05-27. This revision specifies its use to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
Background
Dapagliflozin, marketed as Farxiga, is an oral medication that has been an important treatment option for patients with type 2 diabetes mellitus. Its therapeutic profile has been studied for its effects beyond glycemic control. This latest label update highlights a significant expansion of its recognized benefits, particularly in the context of cardiovascular health outcomes for a specific patient population.
What this means
This label revision provides clinicians with a clearer and formalized indication for using dapagliflozin to address the critical risk of hospitalization due to heart failure. The expanded indication specifically targets adult patients diagnosed with type 2 diabetes mellitus who concurrently present with either established cardiovascular disease or possess multiple cardiovascular risk factors. This update reinforces the drug's role not only in managing blood glucose but also in contributing to broader cardiovascular risk management strategies within this high-risk diabetic population, potentially impacting treatment guidelines and prescribing practices.
Source
The information regarding this label revision was obtained from the FDA. The update to the indication and usage section of the dapagliflozin label was effective on 2026-05-27 and is publicly available on dailymed.nlm.nih.gov, a service of the National Library of Medicine.