The Food and Drug Administration (FDA) has approved Humalog 200 units/mL KwikPen (insulin lispro 200 units/mL [U-200]; Eli Lilly) to improve glycemic control in patients with type 1 and type 2 diabetes. The Humalog U-200 KwikPen is the first concentrated mealtime insulin analog to receive FDA approval.

The new formulation contains twice as many insulin units (600 units) as the U-100 formulation (300 units) in the same 3mL cartridge. The Humalog U-200 KwikPen requires no dose conversions and can be adjusted in 1-unit increments to a maximum of 60 units per injection. The concentrated dosing allows delivery of the same dose as the Humalog U-100 KwikPen but in half the volume.

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The FDA approval was based on bioequivalence data of Humalog 200 units/mL compared to Humalog 100 units/mL in a pharmacokinetic/pharmacodynamic study.

Humalog is a rapid acting human insulin analog. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.

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