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FDA Approves Humulin U500 KwikPen - Bringing Convenient Pen Delivery for Concentrated Insulin

Updated: 8/14/21 6:00 amPublished: 2/9/16

Twitter Summary: @Lilly_Diabetes receives @US_FDA approval for Humulin U500 KwikPen, adding new pen delivery for concentrated insulin - what does it cost?

Lilly just announced FDA approval of its Humulin U500 KwikPen (human insulin injection). Previously, the concentrated Humulin U500 insulin was only offered in a vial-syringe system that required frustrating dose conversions and added inconvenience compared to widely used pens. The new KwikPen delivery system will bring welcome convenience for people who take higher doses of insulin. As we understand it, the U500 KwikPen will launch before July, 2016.

The U500 KwikPen will be priced at a premium relative to the vial-syringe offering, though Lilly says it will be less expensive than basal insulin analog pens such as Toujeo, Tresiba, Lantus, and Levemir. Rising insulin costs remain a significant issue for so many with diabetes, particularly the uninsured and underinsured, and the tradeoff between higher prices compared to increased convenience will undoubtedly vary person to person. However, there will be a Humulin U500 Savings Card Program, available for certain patients (who already have insurance). Under the savings program, the product would be offered for $25/month. Uninsured patients can also access the product through the Lilly Cares program.

Humulin U500 is five times more concentrated than Lilly’s human insulin Humulin U100. That means the Humulin U500 KwikPen will hold 1,500 units of insulin each (five times as many as the 300-unit Humulin U100 KwikPen) and will dial in five-unit increments. The pen itself will be the same size as the Humulin U100 KwikPen, but it will come in a new aqua color to reduce possible confusion with other pens. -ER/AJW

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