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US FDA approves FARXIGA tablets for the treatment of adult patients with type 2 diabetes

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AstraZeneca and Bristol-Myers Squibb Company announced the US Food and Drug Administration (FDA) approved FARXIGA™ [far-SEE-ga] (dapagliflozin), a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. FARXIGA should not be used for the treatment of patients with type 1 diabetes or diabetic ketoacidosis. The recommended starting dose of FARXIGA is 5 mg once daily, taken in the morning, with or without food. In patients tolerating FARXIGA 5 mg once daily who require additional glycaemic control, the dose can be increased to 10 mg once daily. FARXIGA is part of a newer class of medicines called sodium-glucose cotransporter 2 (SGLT2) inhibitors, which remove glucose via the kidneys.

“With the diabetes epidemic escalating and many people with type 2 diabetes struggling to reach their blood sugar goals, FARXIGA offers an important new option for healthcare professionals and adult patients,” said Brian Daniels, Senior Vice President, Global Development and Medical Affairs, Bristol-Myers Squibb. “In clinical trials, FARXIGA helped improve glycaemic control, and offered additional benefits of weight and blood pressure reductions.”

FARXIGA is contraindicated in patients with a history of a serious hypersensitivity reaction to FARXIGA or with severe renal impairment, end stage renal disease, or patients on dialysis.

“The addition of FARXIGA to our US treatment portfolio is a step forward as we work to help reduce the burden of type 2 diabetes by offering a range of treatment options with different modes of action,” said Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca. “We aim to help adults with type 2 diabetes, and their doctors, create individualised treatment programmes that will help patients lower their glucose levels.”

Dapagliflozin (marketed outside of the United States as FORXIGA®) is approved for the treatment of adults with type 2 diabetes, along with diet and exercise, in 40 countries, including European Union countries and Australia.