First concentrated mealtime insulin analog approved

FDA approved Eli Lilly’s Humalog 200 units/mL KwikPen (insulin lispro 200 units/mL; U-200), the company announced on May 27.

The Humalog U-200 KwikPen (insulin lispro 100 units/mL) marks the first FDA approval of a concentrated mealtime insulin analog. The KwikPen holds twice as many units of insulin (600 units vs. 300 units) as the U-100 formulation in the same 3-mL cartridge, offering patients “a pen that lasts longer between pen changes, allowing for fewer changes every month,” according to Eli Lilly.

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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 1-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, MD, vice president of Medical Affairs for 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."

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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.

FDA's. approval follows the approval of Humalog 200 units/mL KwikPen in the European Union in October, 2014.

The most common side effect of Humalog is hypoglycemia (low blood sugar), which may be severe and cause unconsciousness, seizures and death. Other possible adverse events include generalized allergies and anaphylaxis, hypokalemia, fluid retention and heart failure with concomitant use of PPAR-gamma agonists, and hyperglycemia and ketoacidosis due to insulin pump device malfunction.

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