FDA Approves Humulin R U-500 KwikPen

FDA Approves Humulin R U-500 KwikPen

U.S. Food And Drug Administration Approves Humulin R U-500 KwikPen
INDIANAPOLIS, Jan. 21, 2016 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's 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 diabetes 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."
For more information about Humulin R U-500 KwikPen, healthcare professionals can visit www.humulinhcp.com.

About Lilly Patient Assistance Programs

Lilly offers Patient Assistance programs to help people who may not be able to afford their medications. If a patient financially qualifies and meets program criteria, they may be eligible to receive free product for up to one year. For additional information, visit www.LillyCares.com.

About Diabetes

Approximately 29 million Americans¹ and an estimated 415 million people worldwide have type 1 and type 2 diabetes.² Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.¹ Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.¹

About Lilly Diabetes

Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions—from medicines to support programs and more—to make lives better. For more information, visit www.lillydiabetes.com.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.
This press release contains forward-looking statements about Humulin R U-500 KwikPen (500 units/mL) for use in the treatment of diabetes. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that Humulin R U-500 KwikPen will be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
Humulin® R U-500 and Humulin® R U-500 KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

1. Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: U.S. Department of Health and Human Services; 2014.
2. International Diabetes Federation. IDF Diabetes Atlas, 7th ed. Brussels, Belgium: International Diabetes Federation, 2015. http://www.idf.org/diabetesatlas. Accessed January 6, 2016.

SOURCE Eli Lilly and Company