Sanofi’s Admelog (insulin lispro injection) is the first short-acting “follow-on” insulin product for diabetes treatment to gain approval from the US Food and Drug Administration (FDA). The rapid-acting insulin is similar to Humalog and is indicated to improve blood sugar control in adult patients with type 2 diabetes and adults and children over the age of three with type 1 diabetes.
Admelog will be available in vials or in a SoloStar pen, currently the most prevalent disposable insulin pen in the United States, and may be administered via a subcutaneous injection, a subcutaneous infusion, or an intravenous infusion. Short-acting insulin products are generally administered before meals to control blood sugar levels after eating. They differ from long-acting products, for example, Lantus (insulin glargine injection) or Tresiba (insulin degludec injection), which are used to balance insulin levels throughout the day and which are usually administered only once or twice daily.
Approval for Admelog was granted through an abbreviated approval pathway which speeds up approval of products if the FDA has previously found the drug is safe and effective. Admelog is based on Humalog, an Eli Lilly and Company product which gained approval in June 1996.
Following Admelog’s approval, FDA Commissioner Scott Gottlieb, MD, highlighted the importance of increasing competition for prescription drugs and easing the transition of cheaper alternatives into the American market.
“This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease,” he asserted, adding that further policy steps will be made in the coming months to provide effective lower-cost alternatives to brand-name drugs using the agency’s abbreviated pathways.
Last month, Novo Nordisk’s rapid-acting mealtime insulin Fiasp (insulin aspart) gained approved from the FDA. The drug is a formulation of Novolog with the addition of niacinamide (vitamin B3), which increases the speed of the insulin’s initial absorption.
Common Adverse Reactions:
The most common reactions to Admelog in the clinical trials were hypoglycemia, itching, and a rash. Other reactions to the drug included allergic reactions, reactions at the injection site, and lipodystrophy or thickening or thinning of fatty tissue at the injection site.
One of the most severe reactions to Admelog is anaphylaxis. Patients at risk of hypokalemia should have their potassium levels monitored when taking this drug.
Admelog should not be administered when patients suffer from hypoglycemia or to those with a hypersensitivity to insulin lispro or any of the ingredients.
For more information on Admelog, visit https://www.admelogpro.com