Pharmaceutical company AstraZeneca announced Oct. 21 that its drug Farxiga—or dapagliflozin—was approved by the FDA to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes.
The FDA has already granted Farxiga fast-track designation to reduce the risk of CV death or worsening heart failure in adults with HF with reduced ejection fraction or preserved ejection fraction based on the results of the DAPA-HF and DELIVER trials. It was also fast-tracked to delay the profession of renal failure and prevent CV and renal death in patients with chronic kidney disease.
The drug’s latest indication is based on the positive results of the DECLARE-TIMI 58 CV outcomes trial—the largest SGLT2 inhibitor CV outcomes trial to evaluate type 2 diabetes patients with CV risk factors or established CVD to date.
“DECLARE-TIMI 58 is a landmark trial, offering compelling evidence that dapagliflozin can reduce the risk of heart failure in patients living with type 2 diabetes with multiple risk factors for or established cardiovascular disease,” Stephen Wiviott, a senior investigator with the TIMI study group and a physician at Brigham and Women’s Hospital, said in a statement. “These data could help change the way we approach diabetes management, going beyond a singular focus on glucose control to help address the risk of heart failure in a diverse population of patients.”
Farxiga is the first SGLT2 inhibitor approved in the U.S. for this new indication, AstraZeneca reported. It’s currently under regulatory review in China, with a decision expected in the first half of next year.
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.