By Chris Wack
AstraZeneca said Thursday it has been granted fast track designation in the U.S. for the development of Farxiga dapagliflozin to reduce the risk of hospitalization for heart failure or cardiovascular death in adults following an acute myocardial infarction or heart attack.
The company said the designation is based on a Phase III DAPA-MI trial that will explore the efficacy and safety of Farxiga in this patient population.
The DAPA-MI trial is conducted in collaboration with Uppsala Clinical Research Center and Minap in the U.K. It will explore the benefit of Farxiga in patients without type-2 diabetes following an acute MI. It is expected to begin recruiting in the fourth quarter of 2020.
In May, Farxiga was approved in the U.S. to reduce the risk of CV death and hHF in adults with HF with reduced ejection fraction with and without T2D. Farxiga is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. Additionally, Farxiga is being evaluated for patients with chronic kidney disease in the Phase III DAPA-CKD trial, which was stopped early after a Data Monitoring Committee determination of overwhelming efficacy.
Write to Chris Wack at firstname.lastname@example.org