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AstraZeneca, Bristol-Myers diabetes drug OK'd by FDA
January 13th, 2014
WILMINGTON, Del., and PRINCETON, N.J. – AstraZeneca and Bristol-Myers Squibb Co. have received approval from the Food and Drug Administration for diabetes medication Farxiga.
The companies said Monday that Farxiga (dapagliflozin), a once-daily oral treatment, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
With Farxiga, the recommended starting dose is 5 mg once daily, taken in the morning with or without food. In patients tolerating Farxiga 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily.
AstraZeneca and Bristol-Myers noted that 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 health care professionals and adult patients," stated Brian Daniels, senior vice president for global development and medical affairs at Bristol-Myers Squibb. "In clinical trials, Farxiga helped improve glycemic control and offered additional benefits of weight and blood pressure reductions."
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.
"The addition of Farxiga to our U.S. 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," commented Briggs Morrison, executive vice president of global medicines development and chief medical officer at AstraZeneca. "We aim to help adults with type 2 diabetes, and their doctors, create individualized treatment programs that will help patients lower their glucose levels."