October 21, 2019

The US FDA has approved a new indication for Farxiga® (dapagliflozin) tablets, manufactured by AstraZeneca, to reduce the risk of hospitalization for heart failure in adults who have type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors.

Diabetes affects an estimated 30 million individuals in the US and is identified by the American Heart Association as one of seven controllable major risk factors for cardiovascular disease. Patients who have diabetes are two to four times more likely to die of heart disease than those who do not, with an estimated 68% of diabetes patients over the age of 65 dying of heart disease and 16% dying of stroke. Risk factors related to diabetes that contribute to these statistics include high blood pressure, abnormal cholesterol and high triglycerides, obesity, and poorly controlled blood sugar.

In a clinical trial, Farxiga reduced the composite risk of cardiovascular-related death or hospitalization for heart failure by 17% compared to placebo. Treatment with Farxiga lead to a 36% reduction in the rate of hospitalization for heart failure patients who had a reduced ejection fraction (an indicator that the left ventricular muscle of the heart is not pumping as well as it should), and 24% reduction in heart failure patients without a reduced ejection fraction.

Recommended dosing under the new indication is 10mg of Farxiga taken by mouth once daily. The use of Farxiga is not recommended in patients whose eGFR, a measure of kidney function, is less than 46mL/min/1.73m2. The patient’s renal function should be assessed prior to starting treatment with Farxiga, and periodically thereafter.

Farxiga first received FDA approval in 2014 and is also indicated as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes mellitus.

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