The FDA approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

Indications: Adlyxin is a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dosage and administration: Dosage is 10 mcg once daily for 14 days. On day 15, increase dosage to 20 mcg once daily.

Efficacy and safety: The drug’s safety and effectiveness were evaluated in 10 clinical trials that enrolled 5,400 patients with type 2 diabetes. In these trials, Adlyxin was evaluated both as a standalone therapy and in combination with other FDA-approved diabetic medications, including metformin, sulfonylureas, pioglitazone and basal insulin. Use of Adlyxin improved hemoglobin A1c levels in these trials. It was also evaluated in a CV outcomes trial involving more than 6,000 patients, where it did not increase the risk of CV adverse events.

Adverse reactions: The most common adverse reactions are nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia.

Citation: US Food and Drug Administration. FDA approves Adlyxin to treat type 2 diabetes FDA Web site. July 28, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm513602.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed August 1, 2016.