FDA Approves Soliqua 100/33 for Type 2 Diabetes

The approval is based on a Phase 3 study which demonstrated better HbA1c reductions with Soliqua vs. Lantus
The approval is based on a Phase 3 study which demonstrated better HbA1c reductions with Soliqua vs. Lantus

Sanofi announced that the Food and Drug Administration (FDA) has approved Soliqua 100/33 (insulin glargine & lixisenatide injection) for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (<60 units daily) or lixisenatide. 

Soliqua 100/33 is a once-daily injection that combines 100 Units/mL of insulin glargine (Lantus), a long-acting human insulin analog, and 33mcg/mL of lixisenatide, a GLP-1 receptor agonist. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis. Lixisenatide works by increasing glucose-dependent insulin release, decreasing glucagon secretion, and enhancing protein synthesis. 

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In its Phase 3 program (n>1,900), Soliqua 100/33 demonstrated better HbA1c reduction vs. Lantus with the majority of patients (55% vs. 30%) achieving the American Diabetes Association (ADA) target of <7% at 30 weeks. Patients in the Soliqua 100/33 arm also had similar rates of documented (≤70mg/dL) hypoglycemia vs. patients in the Lantus arm. 

Soliqua 100/33 will be available as a single prefilled pen covering 15–60 Units of insulin glargine 100 Units/mL and 5–20mcg of lixisenatide using SoloStar technology. The product will be available in January 2017.

For more information call (800) 633-1610 or visit sanofi.us.