Sanofi cleared by FDA to market Adlyxin

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PARIS — Sanofi has gained Food and Drug Administration approval for Adlyxin (lixisenatide), a medication for type 2 diabetes.

A once-daily mealtime GLP-1 receptor agonist injection, Adlyxin is indicated as an adjunct to diet and exercise for improving blood glucose control in the treatment of adults with type 2 diabetes.Sanofi said this week that Adlyxin 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 increase the dosage to 20 micrograms once daily.

“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,” stated Peter Guenter, executive vice president and head of the Global Diabetes & Cardiovascular Business Unit at Sanofi. “We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled.”

The FDA said Adlyxin’s safety and effectiveness were evaluated in 10 clinical trials that enrolled 5,400 patients with type 2 diabetes. Adlyxin was evaluated both as a stand-alone 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 the trials, the agency said.

Type 2 diabetes affects more than 29 million people and accounts for more than 90% of diabetes cases diagnosed in the United States, the FDA reported.

“The FDA continues to support the development of new drug therapies for diabetes management,” commented Mary Thanh Hai Parks, deputy director of the 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.”

Adlyxin is approved under the proprietary name, Lyxumia in more than 60 countries and marketed in over 40 countries. Commercial launches include most EU countries, Japan, Brazil, Mexico and India. Adlyxin is in-licensed from Zealand Pharma A/S.

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