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FDA Declines Farxiga Approval for Type 1 Diabetes

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FDA Declines Farxiga Approval for Type 1 Diabetes
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British pharmaceutical company AstraZeneca has announced that the U.S. Food and Drug Administration (FDA) has declined to approve its oral diabetes drug dapagliflozin (brand name Farxiga; Forxiga outside the United States) for use in type 1 diabetes. The medicine was granted approval as an adjunct treatment for certain adults with type 1 diabetes by the European Commission earlier this year.

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Farxiga is a member of a class of drugs known as SGLT2 inhibitors and is approved in the United States for the treatment of type 2 diabetes. The FDA declined the company’s application to use the medicine for use in people with type 1 diabetes for whom insulin alone has not be enough to control blood glucose levels.

AstraZeneca did not indicate the reasons the FDA shared for declining the application. The company says it will work closely with the FDA to “discuss the next steps.”

Want to learn more about SGLT2 inhbitors? Read “Diabetes Medicine: SGLT2 Inhbitors.”

Diane Fennell

Diane Fennell

Senior Digital Editor for DiabetesSelfManagement.com, Fennell has 16 years’ experience specializing in diabetes and related health conditions. Based in New York City, she has a degree from Columbia University.

 

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