INDIANAPOLIS — Eli Lilly and Co. has gained Food and Drug Administration approval for the Humulin R U-500 KwikPen, a prefilled device containing a highly concentrated formulation of insulin.

Humulin R U-500 is used to treat people with type 1 and type 2 diabetes who need over 200 units of insulin daily.

Humulin R U-500 is used to treat high blood sugar in people with type 1 and type 2 diabetes who need more than 200 units of insulin per day

Lilly said Thursday that Humulin R U-500 (insulin human injection, 500 units/ml) is the only FDA-approved insulin that is five times more concentrated than standard U-100 insulin. Humulin R U-500 is used to treat high blood sugar in people with type 1 and type 2 diabetes who need more than 200 units of insulin per day.

The company noted that previously Humulin R U-500 was available only in a vial, administered with a U-100 insulin syringe or a volumetric (tuberculin) syringe requiring conversion to respective syringe “unit markings” or volume markings. Though each U-500 KwikPen holds 1,500 units of insulin — the amount in five U-100 insulin pens — it’s the same size as other KwikPens and dials in five-unit increments.

The U-500 KwikPen also sports a unique, aqua-colored pen body to differentiate it from other insulin pens, Lilly added. Healthcare professionals can click here to see the U-500 KwikPen in action.

“People with diabetes and severe insulin resistance who have become poorly responsive to the effects of insulin may require much higher insulin doses — more than 200 units per day — to help keep their blood sugar levels on target,” stated Jeffrey Jackson, M.D., Medical Fellow, U.S. Medical Affairs, for Lilly Diabetes. “For these patients, the U-500 KwikPen is now available as a convenient alternate option to deliver a large dose of insulin in a reasonable volume. It was specifically designed as a dedicated dosing device to eliminate the need for dose conversion, as compared to use of the vial and syringe options, which some people may find to be an improvement.”

Lilly said it’s also offering the Humulin R U-500 Savings Card Program, which enables eligible, commercially insured patients to pay as low as $25 per prescription for up to 12 redemptions over a 12-month period.

“The U-500 KwikPen is another example of Lilly’s ongoing commitment to support people living with diabetes and our leadership in the treatment of diabetes,” Jackson added. “It will provide an additional treatment option to help people with severely insulin-resistant diabetes improve control of their blood sugar levels, with 80% less liquid volume, and usually two or three injections per day.”