AstraZeneca today announced that the U.S. FDA has approved Farxiga (dapagliflozin) to reduce the risk of hospitalization for heart failure in adults with Type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors.
The approval is based on results from the landmark DECLARE-TIMI 58 CV outcomes trial (CVOT), the largest sodium-glucose cotransporter 2 (SGLT2) inhibitor CVOT conducted to date to evaluate T2D patients with multiple CV risk factors or established CV disease.
“Farxiga is the first SGLT2 inhibitor approved in the U.S. to reduce the risk of hospitalization for heart failure in Type 2 diabetes patients with established cardiovascular disease or multiple cardiovascular risk factors,” said Ruud Dobber, executive vice president, biopharmaceuticals business unit.
“This is promising news for the 30 million people living with Type 2 diabetes in the U.S., as heart failure is one of the earliest cardiovascular complications for them, before a heart attack or stroke,” Dobber added.
Dobber said Farxiga now offers the opportunity for physicians to act sooner and reduce the risk of hospitalization for heart failure.
Dr. Stephen Wiviott of Brigham and Women’s Hospital and Harvard Medical School, Boston, and a senior investigator with the TIMI study group and co-principal investigator of the trial, added that the 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.
“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,” Wiviott added.
The FDA approval follows the update to the marketing authorization in the EU in August 2019. Farxiga is also under regulatory review in China with a decision anticipated in the first half of 2020.
For more details, view the complete press release below.
- AstraZeneca. (2019, October 21). FARXIGA Approved in the US to Reduce the Risk of Hospitalization for Heart Failure in Patients With Type 2 Diabetes. Business Wire. Retrieved from https://www.businesswire.com/news/home/20191021005194/en