Sanofi-Aventis's Adlyxin Approved by FDA for Diabetes Treatment

Following extensive clinical trials, the FDA today announced its approval of Adlyxin (lixisenatide), a once-daily injection for glycemic control. Adlyxin is a hormone treatment that works to normalize blood sugar levels, and could become a treatment option for the well-over 25 million Americans living with type 2 diabetes.

Results of 10 trials, which included 5,400 patients and featured the use of lixisenatide treatment both as a standalone and in combination with other treatments, showed the drug was capable of improving hemoglobin A1c levels. Other studies were conducted to determine whether or not Adlyxin posed a threat to type 2 diabetics who were also at risk for atherosclerotic cardiovascular disease. Results from the over 6,000 people tested showed no increase in risk over placebo.

While good news for many diabetes sufferers, the treatment is distinctly not for those suffering type 1 diabetes or those with diabetic ketoacidosis. When used in combination with sulfonylurea and/or basal insulin, increased rates of hypoglycemia were detected. Other side effects include nausea, dizziness, headache, and vomiting, and in severe sensitivity cases, anaphylaxis.

In addition to the existing data, the FDA ordered two post-marketing studies: one to determine efficacy and dosing in pediatric patients, and another to evaluate the drug’s immunogenicity.

“The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes…” said Peter Guenter, Executive Vice President and Head of Sanofi’s Global Diabetes & Cardiovascular Business Unit, today in a statement. “We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled.”