FDA approves Adlyxin for type 2 diabetes

The FDA has approved the once-daily glucagon-like peptide-1 receptor agonist Adlyxin, a once-daily injection to improve glycemic control along with diet and exercise in adults with type 2 diabetes, Sanofi announced in a press release.

"The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose (HbA1c) targets," Peter Guenter, executive vice president and head of the global diabetes and cardiovascular business unit at Sanofi, said in the release. "We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled."

The approval of Adlyxin (lixisenatide) was based on FDA review of results from the GetGoal clinical program and findings from the ELIXA trial, which addressed the FDA's request to demonstrate cardiovascular safety. The GetGoal clinical program included 13 clinical trials involving more than 5,000 adults with type 2 diabetes worldwide to evaluate the safety and efficacy of lixisenatide in adults with type 2 diabetes. The drug was evaluated both as a standalone therapy and in combination with metformin, sulfonylureas, pioglitazone and basal insulin. All studies of the GetGoal program successfully met the primary efficacy endpoint of HbA1c reduction. The most common adverse events reported for lixisenatide included nausea, hypoglycemia and vomiting. In addition, severe hypersensitivity reactions, including anaphylaxis, were reported in clinical trials.

Lixisenatide will be available in a disposable prefilled pen in a single dose of 20 micrograms. Patients will also receive a disposable prefilled pen in a single dose of 10 micrograms that they should initiate once daily for 14 days. On day 15, patients will increase dosage to 20 micrograms once daily.

Lixisenatide is approved under the proprietary name, Lyxumia in more than 60 countries.

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

Lixisenatide should not be used to treat people with type 1 diabetes or patients with diabetic ketoacidosis.

It is not known whether lixisenatide is safe and effective in children. The FDA is requiring post-marketing studies for lixisenatide to evaluate dosing, efficacy and safety in pediatric patients, as well as a study evaluating the immunogenicity of the drug.