The FDA revised the indication and usage section of the dapagliflozin label on 2026-07-09. This update includes a new indication for reducing the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. The label also maintains its indication as an adjunct to diet and exercise for glycemic control.
Background
Dapagliflozin is an oral medication belonging to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Prior to this revision, it was indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The updated label reflects an expanded understanding of the drug's benefits beyond blood sugar management, specifically in addressing cardiovascular outcomes in a high-risk patient population.
What this means
The updated label for dapagliflozin signifies an important expansion of its therapeutic utility for clinicians managing patients with type 2 diabetes mellitus. This formal recognition by the FDA allows healthcare providers to prescribe dapagliflozin with the explicit aim of reducing the risk of hospitalization for heart failure in adults who have type 2 diabetes and either established cardiovascular disease or multiple cardiovascular risk factors. This change reinforces the growing evidence for SGLT2 inhibitors in providing cardiorenal benefits in addition to their glucose-lowering effects, offering a more comprehensive treatment approach for these complex patients.
Source
This information was sourced from the FDA, detailing a label revision for dapagliflozin effective 2026-07-09. The updated label can be found on dailymed.nlm.nih.gov.