FDA Approves New Option for Type 2 Diabetes (lixisenatide)

The FDA has approved lixisenatide as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes.

The drug, a glucagon-like peptide-1 receptor agonist, is administered as a once-daily injection.
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The drug’s safetly and effectiveness were evaluated in 10 clinical trials of 5,400 patients with type 2 diabetes. It was evaluated as both a standalone therapy and in combination with metformin, sulfonylureas, pioglitazone, and basal insulin. Overall, use of lixisenatide improved hemoglobin A1_c levels.

In another study, over 6000 individuals with type 2 diabetes and increased risk for atherosclerotic cardiovascular disease were treated with lixisenatide or placebo. Use of lixisenatide was not associated with an increased risk of adverse cardiovascular events.

The most common side effects experienced with lixisenatide were nausea, vomiting, headache, diarrhea, and dizziness.

—Michael Potts

Reference:

FDA. FDA approves Adlyxin to treat type 2 diabetes [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm513602.htm. July 28, 2016.