USFDA approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.
Mechanism of action
- Lixisenatide is a selective GLP-1 receptor agonist.
- The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from the pancreatic beta cells.
- Lixisenatide action is mediated via a specific interaction with GLP-1 receptors, leading to an increase in intracellular cyclic adenosine monophosphate (cAMP).
- Lixisenatide stimulates insulin secretion when blood glucose is increased but not at normoglycaemia, which limits the risk of hypoglycaemia.
- In parallel, glucagon secretion is suppressed. In case of hypoglycaemia, the rescue mechanism of glucagon secretion is preserved. Lixisenatide slows gastric emptying thereby reducing the rate at which meal-derived glucose appears in the circulation.
Lixisenatide is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.
Dosage and administration:
- Lixisenatide is to be injected subcutaneously in the thigh, abdomen or upper arm.
- Starting dose: dosing is initiated at 10 mcg Lixisenatide once daily for 14 days.
- Maintenance dose: a fixed maintenance dose of 20 mcg Lixisenatide once daily is started on Day 15.
- Lixisenatide 20 micrograms solution for injection is available for the maintenance dose.
- Lixisenatide is administered once daily, within the hour prior to any meal of the day, preferably the same meal each day.
- If a dose of Lyxumia is missed, it should be injected within the hour prior to the next meal.
- The clinical experience in patients ≥75 years is limited. Limited therapeutic experience in patients with moderate renal impairment (creatinine clearance: 30-50 ml/min) and Lixisenatide should be used with caution in this population.
- There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease and therefore, it is not recommended to use Lixisenatide in these populations.
- The safety and efficacy of Lixisenatide in children and adolescents less than 18 years of age have not yet been established.
SAFETY & EFFICACY
- 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.
- In addition, more than 6,000 patients with type 2 diabetes at risk for atherosclerotic cardiovascular disease were treated with either Adlyxin or a placebo in a cardiovascular outcomes trial. Use of Adlyxin did not increase the risk of cardiovascular adverse events in these patients.
- Very common: Hypoglycaemia (in combination with a sulphonylurea and / or a basal insulin). Headache. Nausea, vomiting & diarrhoea; These tend to be mostly mild and transient during the first 3 weeks after starting treatment. Thereafter, they progressively decrease during the following weeks.
- Common: Influenza, upper respiratory tract infection, cystitis & viral infection. Hypoglycaemia (in combination with metformin alone). Dizziness, somnolence, dyspepsia, back pain, injection site pruritus.
- Uncommon: Anaphylactic reaction and urticaria. Please consult the Summary of Product Characteristics in relation to other adverse reactions.
The FDA is requiring the following post-marketing studies for Adlyxin:
- Clinical studies to evaluate dosing, efficacy and safety in pediatric patients.
- A study evaluating the immunogenicity of lixisenatide.
Adlyxin is manufactured by Sanofi-Aventis U.S. LLC, of Bridgewater, New Jersey.
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