October 20, 2019
FDA Approves AstraZeneca's Farxiga for Patients With Type 2 Diabetes
October 21, 2019—AstraZeneca announced that the FDA has approved Farxiga (dapagliflozin) to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.
According to the company, the approval is based on results from the landmark DECLARE-TIMI 58 CV outcomes trial, a large sodium-glucose cotransporter 2 (SGLT2) inhibitor evaluation of patients with type 2 diabetes with multiple CV risk factors or established CVD.
In August, the European Union updated the marketing authorization for Fraxiga, which is also under regulatory review in China with a decision anticipated in the first half of 2020.
In AstraZeneca’s announcement, Stephen Wiviot, MD, who is a senior investigator with the thrombolysis in myocardial infarction study group and coprincipal investigator of the trial commented, “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 [CVD]. 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.” Dr. Wiviot is from Brigham and Women’s Hospital and Harvard Medical School in Boston, Massachusetts.
The company advised that FDA Fast Track designation was granted for Farxiga to reduce the risk of CV death, or the worsening of heart failure in adults with heart failure with reduced ejection fraction or preserved ejection fraction based on the phase III trials, DAPA-HF and DELIVER.
Results from DAPA-HF were recently announced by the company. Farxiga met the primary composite endpoint with a statistically significant and clinically meaningful reduction of CV death or worsening heart failure compared with placebo.
Additionally, Fast Track designation was granted for the Farxiga to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease based on the phase III DAPA-CKD trial. Farxiga is not indicated to reduce the risk of heart failure, CV death, or kidney disease, stated AstraZeneca.