Adlyxin (lixisenatide)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved July 2016

Specific Treatments:

type II diabetes

Therapeutic Areas

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General Information

Adlyxin (lixisenatide) is a once-daily glucagon-like peptide-1 receptor agonist (GLP-1 RA). GLP-1 is a peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells. Adlyxin increases glucose-dependent insulin release, decreased glucagon secretion, and slows gastric emptying.

Adlyxin is specifically indicated as an adjunct to diet and exercise for the treatment of adults with type II diabetes.

Adlyxin is supplied in a disposable pre-filled pen in a single dose of 20 micrograms for subcutaneous administration. Patients will also receive a disposable pre-filled pen in a single dose of 10 micrograms that they should initiate once daily for 14 days.  On Day 15, patients should increase dosage to 20 micrograms once daily.

Clinical Results

FDA Approval

The FDA approval of Adlyxin was based on the GetGoal clinical program, which included 13 clinical trials involving more than 5,000 adults with type II diabetes worldwide. All studies of the GetGoal program successfully met the primary efficacy endpoint of HbA1c reduction. The GetGoal programme established the efficacy and safety profile of lixisenatide 20 µg once daily across the spectrum of patients with type 2 diabetes, including patients not treated with anti-diabetic agents, those failing on oral agents and as an adjunct to basal insulin therapy. The main efficacy endpoints were met in all studies, with the baseline to endpoint reductions in HbA1c consistently ranging from 0.7% to 1.0%. In a head-to-head comparison with exenatide 10 μg twice daily, lixisenatide 20 μg once daily was non-inferior for HbA1c reduction, achieved with threefold fewer patients with symptomatic hypoglycemia events and better gastrointestinal tolerability. Three randomised trials of lixisenatide treatment added to basal insulin showed significantly improved glycemic control over placebo, with pronounced postprandial glucose reductions and good tolerability. 

Side Effects

Adverse effects associated with the use of Adlyxin may include, but are not limited to, the following:

  • nausea
  • vomiting
  • headache
  • diarrhea
  • dizziness
  • hypoglycemia

Mechanism of Action

Adlyxin (lixisenatide) is a once-daily glucagon-like peptide-1 receptor agonist (GLP-1 RA). GLP-1 is a peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells. Adlyxin increases glucose-dependent insulin release, decreased glucagon secretion, and slows gastric emptying.

Additional Information

For additional information regarding Adlyxin or type II diabetes, please visit http://products.sanofi.us/Adlyxin/Adlyxin.pdf