The FDA approval was based on data from the GetGoal clinical program and the ELIXA trial, which addressed the Agency’s request to show cardiovascular safety. The GetGoal program, which involved >5,000 adults with type 2 diabetes, assessed the safety and efficacy of lixisenatide in adults with type 2 diabetes. All 13 studies of the GetGoal program achieved the primary efficacy endpoint of HbA1c reduction.
The most commonly reported adverse events with Adlyxin included nausea, hypoglycemia, and vomiting. Adlyxin was studied as monotherapy and in combination with other antidiabetics, including metformin, sulfonylureas, pioglitazone, and basal insulin.
Adlyxin is a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist that works by increasing glucose-dependent release, decreasing glucagon secretion, and slowing gastric emptying.
Adlyxin is available as 3mL disposable prefilled pens. The starter pen contains 50mcg/mL and delivers 14 doses of 10mcg. The maintenance pen contains 100mcg/mL and delivers 14 doses of 20mcg. The Starter Pack contains 1 prefilled starter pen and 1 prefilled maintenance pen; the Maintenance Pack contains 2 prefilled maintenance pens.
For more information call (800) 446-6267 or visit sanofi-aventis.us.