The first generic of dapagliflozin (Farxiga) tablets for adults with type 2 diabetes has been given the green light by the US Food & Drug Administration (FDA), reports MedPage Today.
Generics of the SGLT2 inhibitor are indicated for glycaemic control (alongside diet and exercise) and for reducing the risk of heart failure hospitalisations among patients with established cardiovascular disease or multiple CVD risk factors.
Dapagliflozin was first approved in 2014 and works by reducing the reabsorption of glucose and sodium in the kidneys. The branded version has also picked up indications for glycaemic control in children with type 2 diabetes and for treating patients with heart failure and chronic kidney disease (CKD).
The drug has also shown some promise in metabolic dysfunction-associated steatohepatitis, with or without type 2 diabetes.
“The prescribing information for the generic dapagliflozin tablets includes the same contraindications, warnings, and precautions as Farxiga,” the FDA stated.
“Dapagliflozin is contra-indicated in patients with a history of a serious hypersensitivity reaction to dapagliflozin or any of the excipients, and carries warnings such as diabetic ketoacidosis in patients with type 1 diabetes mellitus and other ketoacidosis, and volume depletion.”
Dapagliflozin is not approved for use in type 1 diabetes, but research shows its use growing among patients with heart failure or CKD and concurrent type 1 diabetes.
Common adverse events reported in trials include female genital mycotic infections, nasopharyngitis, and urinary tract infections. Labelling also carries warnings regarding urosepsis, pyelonephritis, hypoglycaemia, Fournier's gangrene, and genital mycotic infections.
Dapagliflozin is available in 5 mg and 10 mg tablets and is taken once daily in the morning.
MedPage Today article – FDA Approves First Farxiga Generics for Type 2 Diabetes (Open access)
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