FDA Approves Adlyxin for Treatment of Type 2 Diabetes in Adults

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The U.S. Food and Drug Administration has approved the drug Adlyxin, a once a day injection that along with diet and exercise improves blood sugar levels in adults with type 2 diabetes.

“The FDA continues to support the development of new drug therapies for diabetes management,” said Mary Thanh Hai Parks, M.D., 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.”

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 (a measure of blood sugar levels) in these trials.

The FDA added that Adlyxin should not be used to treat people with type 1 diabetes or patients with increased ketones in their blood or urine –known as diabetic ketoacidosis.

“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,” said Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi.

“We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled.”

Common side effects

The most common side effects associated with Adlyxin are nausea, vomiting, headache, diarrhea and dizziness. Hypoglycemia in patients treated with both Adlyxin and other antidiabetic drugs such as sulfonylurea and/or basal insulin is another common side effect. In addition, severe hypersensitivity reactions, including anaphylaxis, were reported in clinical trials of Adlyxin.

Adlyxin is manufactured by Sanofi-Aventis U.S. LLC, of Bridgewater, New Jersey.

Type 2 diabetes affects more than 29 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness and nerve and kidney damage

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