FDA approves Dapagliflozin to reduce risk of Heart Failure in Diabetes

The US Food and Drug Administration has approved the diabetes drug dapagliflozin (marketed as Farxiga) to reduce the risk for heart failure hospitalization in adults with type 2 diabetes plus established cardiovascular disease or cardiovascular risk factors.The sodium-glucose cotransporter 2 (SGLT2) inhibitor, Dapagliflozin is the first in its class to be approved for this use, according to the manufacturer.

Dapagliflozin is oral once-daily SGLT2 inhibitor indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood pressure reduction, as an adjunct to diet and exercise in adults with T2D.

Dapagliflozin was first approved to treat type 2 diabetes in 2014. Approval for the new use was based on results from the DECLARE-TIMI 58 trial, in which patients with diabetes and high cardiovascular risk who received the drug had a lower rate of heart failure hospitalization or cardiovascular death than those on placebo.

The approval by the U.S. Food and Drug Administration is based on results from the DECLARE-TIMI 58 clinical trial in which patients with diabetes and high cardiovascular risk who received the drug had a lower rate of heart failure hospitalization or cardiovascular death than those on placebo.

Farxiga is the first of its class to be approved in the United States for this indication, Ruud Dobber, executive vice president of BioPharmaceuticals at AstraZeneca said.

The US Food and Drug Administration approval follows the update to the marketing authorisation in the EU in August 2019. Farxiga is also under regulatory review in China with a decision anticipated in the first half of 2020.

The US Food and Drug Administration has granted Fast Track designation for Farxiga to reduce the risk of CV death, or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) based on the Phase III DAPA-HF and DELIVER trials, and Fast Track designation to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease (CKD) based on the Phase III DAPA-CKD trial.

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