Lilly receives FDA approval for Humulin R U-500 KwikPen

Eli Lilly and CompanyJan 21 2016

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's (NYSE: LLY) Humulin^® R U-500 KwikPen^®(insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. Humulin R U-500 is the only FDA-approved insulin that is five-times more concentrated than standard U-100 insulin. This insulin 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 safety and efficacy of Humulin R U-500 used in combination with other insulins or delivered by an insulin infusion pump has not been determined.

"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," said Jeffrey A. Jackson, MD, FACE, CDE, Medical Fellow, US Medical Affairs, 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."

Until now, Humulin R U-500 was only available in a vial, administered with either a U-100 insulin syringe or a volumetric (tuberculin) syringe that requires conversion to respective syringe "unit markings" or volume markings. Although each U-500 KwikPen holds 1500 units of insulin (the amount in five U-100 insulin pens), it is the same size as other KwikPens and dials in five-unit increments. The U-500 KwikPen has a unique aqua-colored pen body to clearly differentiate it from other insulin pens. Healthcare professionals can click here to see the U-500 KwikPen in action.

Humulin R U-500 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Humulin R U-500 or any of its additives or components. Hypoglycemia (low blood sugar) is the most common side effect associated with all insulins, including Humulin R U-500. See the Important Safety Information at the end of this press release, Prescribing Information and Patient Information.

The Humulin R U-500 Savings Card Program offers eligible, commercially insured patients the opportunity to pay as little 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," said Dr. Jackson. "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."