The US Food and Drug Administration (FDA) has approved Sanofi-Aventis’ short-acting insulin Admelog (insulin lispro injection) for improved control of blood sugar levels in people suffering from diabetes mellitus.
Admelog is indicated for type 1 diabetes mellitus patients aged three years and above, and to treat adults with type 2 diabetes mellitus.
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The drug can be administered through subcutaneous injection or infusion, or by intravenous infusion.
Its dosing will depend on the administration route, individual metabolic needs, blood glucose monitoring results and glycaemic control goal.
Sanofi-Aventis submitted an application that was partially based on the FDA’s safety and effectiveness findings for Humalog (insulin lispro injection).
The application also included Admelog-specific data from two Phase III clinical trials conducted in about 500 patients to validate the product’s safety and efficacy for approved uses.
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By GlobalDataDuring the trials, the most common Admelog-related adverse reactions were found to be hypoglycaemia, itching, and rash.
FDA Commissioner Scott Gottlieb said: “One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives.
“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.
“In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand-name drugs approved through the agency’s abbreviated pathways.”
