FDA Approves New Long-Acting Insulin

By Diane Fennell | March 6, 2015 2:00 pm

On February 25, 2015, the U.S. Food and Drug Administration (FDA) approved the once-daily, long-acting insulin Toujeo (generic name insulin glargine 300 U/ml) for controlling blood glucose in adults with Type 1[1] and Type 2 diabetes[2]. The medicine, which is manufactured by pharmaceutical company Sanofi, joins basal insulins Lantus (insulin glargine 100 U/ml) and Levemir (insulin detemir) on the U.S. market.

Basal, or background insulin, is typically taken once daily to cover the liver’s secretion of glucose into the bloodstream. Toujeo has the same active ingredient as Lantus, but it is three times the concentration[3] and is designed to release more gradually. In a series of international studies involving more than 3,500 adults with Type 1 and Type 2 diabetes, Toujeo produced similar blood glucose control to Lantus, but with lower rates of hypoglycemia[4] (low blood glucose).

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This medicine should not be used in people under 18 or to treat diabetic ketoacidosis[5] (a potentially life-threatening condition marked by a chemical imbalance in the body). The most common side effects of Toujeo (apart from hypoglycemia) are nasopharyngitis (inflammation of the nose and pharynx) and upper respiratory tract infection.

Toujeo is expected to debut in the United States in April 2015 and will be available in the Toujeo SoloSTAR, a prefilled, disposable pen containing 450 units of the medicine. Information on pricing is not currently available.

For more information about Toujeo, see the press release on Sanofi’s website[6] or visit the official Toujeo website[7]. And to learn more about using long-acting insulin, see “Getting Down to Basals,”[8] by 2014 Diabetes Educator of the Year Gary Scheiner.

Endnotes:
  1. Type 1: http://www.diabetesselfmanagement.com/diabetes-resources/definitions/type-1-diabetes/
  2. Type 2 diabetes: http://www.diabetesselfmanagement.com/diabetes-resources/definitions/type-2-diabetes/
  3. three times the concentration: http://www.reuters.com/article/2015/02/26/us-sanofi-sa-diabetes-toujeo-idUSKBN0LU04C20150226
  4. hypoglycemia: http://www.diabetesselfmanagement.com/diabetes-resources/definitions/hypoglycemia/
  5. diabetic ketoacidosis: http://www.diabetesselfmanagement.com/diabetes-resources/definitions/ketoacidosis/
  6. Sanofi’s website: http://www.news.sanofi.us/2015-02-25-Sanofi-Receives-FDA-Approval-of-Once-Daily-Basal-Insulin-Toujeo%20
  7. official Toujeo website: http://www.news.sanofi.us/2015-02-25-Sanofi-Receives-FDA-Approval-of-Once-Daily-Basal-Insulin-Toujeo
  8. “Getting Down to Basals,”: http://www.diabetesselfmanagement.com/managing-diabetes/treatment-approaches/getting-down-to-basals/

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Diane Fennell: Diane Fennell has been an editor at Diabetes Self-Management magazine since 2003. She is currently the Senior Digital Editor for Diabetes Self-Management E-News and DiabetesSelfManagement.com. (Diane Fennell is not a medical professional.)

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