WRITTEN BY:T’ara Smith
On Monday, October 21, 2019, the U.S. Food and Drug Administration (FDA) approved AstraZeneca’s diabetes drug, Farxiga, for use in the U.S. to treat and reduce the risks of hospitalization from heart failure in adults with Type 2 diabetes and other cardiovascular risks.
“This is promising news for the 30 million people living with Type 2 diabetes in the United States, as heart failure is one of the earliest cardiovascular complications for them, before heart attack or stroke. Farxiga now offers the opportunity for physicians to act sooner and reduce the risk of hospitalization for heart failure,” said Ruud Dobber, executive vice president of BioPharmaceuticals at AstraZeneca.
Already approved by European authorities in August, the States-based approval is based on the results from the DECLARE-IMI 58 clinical trial, in which more than 17,000 patients with diabetes and heart disease were involved. In the third phase of the trial, Farxiga achieved a statistically significant reduction in its primary outcome to reduce hospitalization for heart failure or cardiovascular death versus placebo.
One of the trial’s senior investigators and co-principal investigator, Dr. Stephen Wiviott of Brigham and Women’s Hospital and Harvard Medical School, remarked: “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.”
Farxiga, which is part of the class of drugs called SGLT-2, is the first of its class to be approved in the United States to decrease the chances of hospitalizations from heart failure in those with Type 2 with a history of cardiovascular risk and disease. SGLT-2 inhibitors lower blood glucose by preventing the kidneys from reabsorbing glucose back into the blood and as a result, glucose is excreted through urine. Invokana, another SGLT-2 was approved by the FDA in September to treat kidney disease in people with Type 2 diabetes. SGLT-2s are taken once per day orally and have other benefits such as a low risk for hypoglycemia, weight loss, lower blood pressure, and lower A1c.