FDA approves Lilly's reformulated insulin to foster patient convenience

Humalog U-200 KwikPen--Courtesy of Eli Lilly

The FDA approved an enhanced version of Eli Lilly's ($LLY) Humalog U-200 KwikPen, meaning patients now have access to a concentrated mealtime insulin analog. Due to the iteration's increased concentration, the KwikPen holds twice as many units of insulin, although the three-millimeter cartridge remains unchanged.

As before, Humalog should be taken 15 minutes before or immediately after a meal.

The U-200 delivers the same dosage of insulin in half the volume compared to its predecessor, the U-100. The U-200 name is derived from the pen holding 200 units of insulin per milliliter.

Lilly touted the increased convenience from having 600 units of insulin per pen, such as a longer lasting KwikPen drug delivery device. "Diabetes is a progressive disease that often requires increased doses of insulin over time to better control a patient's blood sugar levels," said Dr. David Kendall, Lilly's vice president of medical affairs, in a statement. "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 new formulation received European approval in October 2014.

The approval came following a bioequivalence study finding that Humalog U-200 has similar pharmacokinetics and pharmacodynamics to the U-100. But, there are some differences regarding the U-200 when it comes to administration. U-100 can be taken intravenously under medical supervision, but not U-200, Lilly says. Also, U-100 can be mixed with a certain insulin if injected subcutaneously, but Lilly warns against mixing U-200 in a syringe with any other insulin.

Humalog had just over $3 billion in annual sales last year, making it one of 7 billion-dollar diabetes blockbusters.

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