New Type 2 Diabetes Medication Approved by FDA

On July 28, the U.S. Food and Drug Administration (FDA) approved the injectable diabetes medication Adlyxin (generic name lixisenatide) for use, along with a healthful diet and exercise, in adults with Type 2 diabetes[1]. The medicine, a development of Sanofi, joins Victoza (liraglutide), Byetta (exenatide), Bydureon (exenatide), Tanzeum (albiglutide), and Trulicity (dulaglutide) as a member of the class of drugs known as glucagon-like peptide-1 (GLP-1) agonists[2].

GLP-1 agonists work by stimulating the insulin-producing beta cells[3] of the pancreas to release insulin in response to high blood glucose levels. Because of their glucose-dependent mechanism of action, drugs of this class are associated with a low rate of hypoglycemia[4] (low blood glucose).

The medicine, which is currently approved in more than 60 countries under the brand name Lyxumia, is injected once daily[5] within an hour before the first meal of the day from a disposable, prefilled pen containing 14 preset 20-microgram doses. (For the first 14 days, users receive a disposable, prefilled pen with 14 preset 10-microgram doses, switching to the 20-microgram dose on day 15.) The safety and effectiveness of Adlyxin were established through findings from the GetGoal clinical program, which showed that the medicine reduced HbA1c[6] levels in 13 trials involving more than 5,000 adults with Type 2 diabetes, as well as results of the ELIXA trial, a cardiovascular-safety study.

The FDA is requiring a number of trials of Adlyxin once it is on the market, including several to determine the medicine’s dosing, effectiveness, and safety in children and one to evaluate whether Adlyxin can cause an immune response in the body.

The medicine should not be used to treat people with Type 1 diabetes[7] or diabetic ketoacidosis[8] (a potentially life-threatening condition marked by a chemical imbalance in the body).

The most common side effects in people using this medicine are headache, nausea, vomiting, diarrhea, and dizziness. In people taking Adlyxin along with another diabetes drug such as a sulfonylurea or basal insulin, hypoglycemia is another common side effect. Severe reactions such as anaphylaxis were reported in clinical trials.

For more information, read the article “GLP-1 Agonist Lixisenatide (Adlyxin) Okayed for Type 2 Diabetes in U.S.”[9] or see the press releases on the Sanofi[10] and FDA[11] websites.

At age 59, Theresa May has become the first major world leader with Type 1 diabetes. Bookmark DiabetesSelfManagement.com[12] and tune in tomorrow to learn more.

Endnotes:
  1. Type 2 diabetes: https://www.diabetesselfmanagement.com/diabetes-resources/definitions/type-2-diabetes/
  2. glucagon-like peptide-1 (GLP-1) agonists: https://www.diabetesselfmanagement.com/blog/non-insulin-injectable-diabetes-medications/
  3. beta cells: https://www.diabetesselfmanagement.com/articles/diabetes-definitions/beta_cells
  4. hypoglycemia: https://www.diabetesselfmanagement.com/articles/diabetes-definitions/hypoglycemia
  5. injected once daily: http://products.sanofi.us/Adlyxin/Adlyxin.pdf
  6. HbA1c: https://www.diabetesselfmanagement.com/articles/diabetes-definitions/hba1c
  7. Type 1 diabetes: https://www.diabetesselfmanagement.com/diabetes-resources/definitions/type-1-diabetes/
  8. diabetic ketoacidosis: https://www.diabetesselfmanagement.com/managing-diabetes/blood-glucose-management/diabetic-ketoacidosis/
  9. “GLP-1 Agonist Lixisenatide (Adlyxin) Okayed for Type 2 Diabetes in U.S.”: http://www.medscape.com/viewarticle/866766
  10. Sanofi: http://www.news.sanofi.us/2016-07-27-Sanofi-Receives-FDA-Approval-of-AdlyxinTM-for-Treatment-of-Adults-with-Type-2-Diabetes
  11. FDA: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm513602.htm
  12. DiabetesSelfManagement.com: https://www.diabetesselfmanagement.com

Source URL: https://www.diabetesselfmanagement.com/blog/new-type-2-diabetes-medication-approved-fda/


Diane Fennell: Diane Fennell has been an editor at Diabetes Self-Management magazine since 2003. She is currently the Editorial Director. (Diane Fennell is not a medical professional.)

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