New Insulin Pen Strength Gets FDA Nod

Treatment is the first concentrated mealtime insulin analog to be approved by the FDA.

The FDA today approved a new 200 unit/mL formulation of Eli Lilly and Company’s pre-filled pen containing insulin lispro (Humalog U-200 KwikPen) for the improvement of glycemic control in patients with type 1 and type 2 diabetes.

As the first concentrated mealtime insulin analog to receive FDA approval, the Humalog U-200 KwikPen delivers the same dose as Lilly’s Humalog U-100 KwikPen in half the volume. Compared with the 300 units of insulin held by the U-100 formulation, the U-200 KwikPen holds 600 units, allowing diabetics to change their pens less frequently.

“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, in a press release. “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.”

The FDA based its approval on data that demonstrated the bioequivalence of Humalog U-200 relative to Humalog U-100 in a pharmacokinetic/pharmacodynamic study. The most common adverse event associated with the use of Humalog is hypoglycemia, which in severe cases may lead to unconsciousness, seizures, and death.

“We are proud to advance our commitment to supporting people with diabetes,” stated Lilly Diabetes vice president Mike Mason. “Humalog U-200 KwikPen is an example of our work to improve the patient experience.”