FDA Approves Novel Type 2 Diabetes Treatment

The FDA recently approved Adlyxin (lixisenatide) to treat patients with type 2 diabetes. The drug is a once-daily injection that, in addition to diet and exercise, will improve glycemic control, according to a press release from the FDA.

Adlyxin is a glucagon-like peptide-1 receptor antagonist, which helps maintain normal blood sugar levels.

The approval was based on 10 clinical trials that included 5400 patients with type 2 diabetes. In the trials, the safety and efficacy of Adlyxin was evaluated as a monotherapy, as well as in combination with other approved medications,such as metformin.

The study showed that hemoglobin A1c levels were improved with the new drug, according to the FDA. In a cardiovascular outcomes trial, Adlyxin was evaluated in 6000 patients with type 2 diabetes who were at risk for developing atherosclerotic cardiovascular disease.

Researchers did not find the drug to cause this risk to increase further. The FDA warns that Adlyxin should not be used in patients with type 1 diabetes, or patients with diabetic ketoacidosis.

The most common adverse effects included nausea, vomiting, headache, diarrhea, and dizziness. Using Adlyxin with another antidiabetic drug could potentially lead to hypoglycemia, the FDA reported.

“The FDA continues to support the development of new drug therapies for diabetes management,” said Mary Thanh Hai Parks, MD, deputy director, Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.”