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Lilly marks a first with Humalog U-200 KwikPen

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INDIANAPOLIS — Eli Lilly and Co. has been cleared by the Food and Drug Administration to market the Humalog 200 units/ml KwikPen, which the company called the first concentrated mealtime insulin analog approved in the United States.

Lilly said Wednesday that the Humalog 200 units/ml KwikPen (insulin lispro 200 units/ml, U-200) is a prefilled pen containing a concentrated formulation of the company’s rapid-acting insulin Humalog (insulin lispro 100 units/ml), indicated to improve glycemic control in adults and children with type 1 or type 2 diabetes.

The company noted that Humalog U-200 KwikPen holds twice as many units of insulin as the U-100 formulation — 600 units versus 300 units — in the same 3-ml cartridge, providing patients with a pen that lasts longer between pen changes, in turn allowing for fewer changes every month.

The 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.

“Diabetes is a progressive disease that often requires increased doses of insulin over time to better control a patient’s blood sugar levels,” stated David Kendall, vice president of medical affairs at Lilly Diabetes. “Humalog U-200 KwikPen represents a new option for people with diabetes. Fewer pen changes per month may help people who require higher daily doses of mealtime insulin better fit their treatment in their daily lives.”

Lilly said the Humalog U-200 KwikPen expands its roster of medicines for people with type 1 or type 2 diabetes. The U.S. approval follows the European Union’s approval of Humalog 200 units/ml KwikPen in October.

“We are proud to advance our commitment to supporting people with diabetes,” commented Mike Mason, U.S. vice president for Lilly Diabetes. “Humalog U-200 KwikPen is an example of our work to improve the patient experience. This product is the newest addition to Lilly’s growing portfolio of diabetes treatment options for people in the United States.”


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