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FDA approves larger capacity Humalog insulin pen
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The FDA recently approved a 200 units/mL Humalog KwikPen, a pre-filled, rapid-acting insulin pen designed to improve glycemic control in people with type 1 and type 2 diabetes, Eli Lilly and Company announced in a press release.
The Humalog KwikPen (insulin lispro 200 units/mL; U-200), the first concentrated mealtime insulin analogue in the U.S., holds twice as many units of insulin (600 units vs. 300 units) as the U-100 formulation in the same 3-mm cartridge, offering a longer-lasting option for people with diabetes. The U.S. approval follows the European Union approval of Humalog 200 units/mL KwikPen in Oct. 2014.
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.
David Kendall , M.D., vice president of medical affairs for Lilly Diabetes, called the drug a new treatment option for those requiring increasing levels of insulin.
“Diabetes is a progressive disease that often requires increased doses of insulin over time to better control a patient's blood sugar levels," Kendall said in a statement. “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.
Humalog is a rapid-acting human insulin analogue indicated to improve glycemic control in adults and children. The most common side effect of Humalog is hypoglycemia that may be severe and cause unconsciousness, seizures and death.
"We are proud to advance our commitment to supporting people with diabetes," Mike Mason, vice president, U.S., Lilly Diabetes, said in a statement. "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."