Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor intended to treat heart failure with reduced ejection fraction in adults
The AstraZeneca R&D facility in Mölndal, Sweden. (Credit: Erik031/Wikipedia.)
AstraZeneca has secured the US Food and Drug Administration (FDA) approval for Farxiga (dapagliflozin) oral tablets to treat a type of heart failure in adults.
The FDA approval indicated Farxiga for the treatment of adults with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalisation for heart failure.
Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor intended to treat adults with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction.
Heart failure is a condition, where the heart fails to pump enough blood to support the body’s needs, and heart failure with reduced ejection fraction occurs when the heart’s left ventricle becomes weak.
FDA’s Center for Drug Evaluation and Research cardiology and nephrology division director Norman Stockbridge said: “Heart failure is a serious health condition that contributes to one in eight deaths in the U.S. and impacts nearly 6.5 million Americans.
“This approval provides patients with heart failure with reduced ejection fraction an additional treatment option that can improve survival and reduce the need for hospitalisation.”
Farxiga improved survival and reduced hospitalisation in adults with heart failure
The company has previously secured FDA approval for Farxiga to improve glycemic control in adults with type-2 diabetes and to reduce the risk of hospitalisation for heart failure in adults with type-2 diabetes and known cardiovascular disease or other risk factors.
A randomised, double-blind, placebo-controlled clinical trial has been conducted on 4,744 participants, to evaluate the safety and effectiveness of Farxiga.
The occurrence of cardiovascular death, hospitalisation for heart failure, and urgent heart failure visits were examined in the study, to determine the effectiveness of the drug.
Farxiga has improved the survival and reduced the need for hospitalisation in adults with heart failure with reduced ejection fraction.
Farxiga is said to cause dehydration, serious urinary tract infections and genital yeast infections, along with serious cases of necrotising fasciitis of the perineum (Fournier’s Gangrene) in people with diabetes and low blood sugar when combined with insulin.