The Food and Drug Administration (FDA) has granted Fast Track designation to dapagliflozin (Farxiga; AstraZeneca) to reduce the risk of hospitalization for heart failure or cardiovascular (CV) death in adults following an acute myocardial infarction (MI).
The designation is based on the multicenter, double-blind, phase 3 DAPA-MI trial that will assess the efficacy and safety of dapagliflozin in reducing the risk of hospitalization for heart failure and CV death in adults without type 2 diabetes following an acute MI. The trial will be conducted under the Special Protocol Assessment (SPA) agreement and integrates routine care and patient registries. It will enroll approximately 6400 patients randomized to receive either dapagliflozin 10mg once daily or placebo. The Company expects to begin recruiting in the fourth quarter of 2020.
Additionally, dapagliflozin is being investigated as a treatment to delay the progression of renal failure and prevent CV/renal death in patients with chronic kidney disease (CKD) in the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.
“The phase 3 DAPA-MI trial is the first indication-seeking registry-based randomised controlled trial which will provide quicker access to data and reduce recruitment time and cost, while minimizing patient and investigator burden,” said Mene Pangalos, Executive Vice President, AztraZeneca BioPharmaceuticals R&D. “Today’s FDA decision acknowledged the importance of this trial, which will provide valuable insights into Farxiga’s potential in patients who had a heart attack and went on to develop heart failure and also into how we can improve clinical trial design in the future.”
Farxiga, a sodium-glucose cotransporter (SGLT2) inhibitor, is already approved to reduce the risk of CV death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction with and without type 2 diabetes.
It is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; and to reduce the risk of hospitalization for HF in adults with type 2 diabetes mellitus and established CV disease or multiple CV risk factors.
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