The US Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Humalog 200 units/mL KwikPen (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly’s rapid-acting insulin Humalog (insulin lispro 100 units/mL) to improve glycemic control in people with Type 1 and type 2 diabetes, Eli Lilly and Company said that the Humalog U-200 KwikPen marks the first FDA approval of a concentrated mealtime insulin analog. Humalog U-200 KwikPen holds twice as many units of insulin (600 units vs. 300 units) as the U-100 formulation in the same three-milliliter cartridge. This offers patients a pen that lasts longer between pen changes, allowing for fewer changes every month.* Humalog U-200 KwikPen delivers the same dose in half the volume of Humalog U-100 KwikPen with no dose conversions required, and can be dialed in one-unit increments to a maximum of 60 units per injection.

The US approval follows the approval of Humalog 200 units/ml KwikPen in the European Union in October 2014.

Source: Eli Lilly and Company