Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has approved 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. 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.
"Diabetes is a progressive disease that often requires increased doses of insulin over time to better control a patient's blood sugar levels," said David Kendall, M.D., vice president, medical affairs, 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."
Approval was based on a demonstration of the bioequivalence of Humalog 200 units/mL relative to Humalog 100 units/mL in a pharmacokinetic/ pharmacodynamic study. The most common side effect of Humalog is hypoglycemia (low blood sugar) that may be severe and cause unconsciousness, seizures and death. See the Important Safety Information at the end of this press release, Prescribing Information, and Patient Information.
"We are proud to advance our commitment to supporting people with diabetes," said Mike Mason, vice president, U.S., 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."
The U.S. approval follows the approval of Humalog 200 units/ml KwikPen in the European Union on October 3, 2014.