Bristol

The US Food and Drug Administration (FDA) has approved AstraZeneca and Bristol-Myers Squibb‘s (BMS) FARXIGA (dapagliflozin), a once-daily oral treatment for the improvement of glycaemic control in adults with type 2 diabetes mellitus.

According to the firms, FARXIGA should not be used to treat patients with type 1 diabetes or diabetic ketoacidosis.

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Initial dose of the drug is 5mg and it should be administered in the morning, with or without food and in patients tolerating the dose who need additional glycaemic control, the dose can be increased to 10mg once daily.

The new drug is part of a newer class of medicines called sodium-glucose cotransporter 2 (SGLT2) inhibitors, which remove glucose through the kidneys.

Bristol-Myers Squibb senior vice-president of global development and medical affairs Brian Daniels said with the diabetes epidemic escalating, many people with type 2 diabetes struggling to reach their blood sugar goals.

“In clinical trials, FARXIGA helped improve glycaemic control, and offered additional benefits of weight and blood pressure reductions.”

“In clinical trials, FARXIGA helped improve glycaemic control, and offered additional benefits of weight and blood pressure reductions,” Daniels said.

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The company said that FARXIGA should not be used in patients who have a history of serious hypersensitivity reaction to the drug or with severe renal impairment, end stage renal disease, or patients on dialysis.

AstraZeneca executive vice-president of global medicines development and chief medical officer Briggs Morrison said: “We aim to help adults with type 2 diabetes, and their doctors, create individualised treatment programmes that will help patients lower their glucose levels.”

Outside the US, dapagliflozin is marketed as FORXIGA, and is approved to treat adults with type 2 diabetes, along with diet and exercise, in 40 countries, including EU countries and Australia.

Image: A research campus operated by Bristol-Myers Squibb in Princeton, New Jersey. Photo: courtesy of Coolcaesar.