A key Eli Lilly and Co. (NYSE: LLY) diabetes treatment technology has been recommended for approval by the European Medicines Agency. The Indianapolis-based company says the new Humalog KwikPen holds twice as much insulin as the current model. July 30, 2014

News Release

INDIANAPOLIS, Ind. – Eli Lilly and Company (NYSE: LLY) today announced that the Committee for Medicinal Products for Human Use (CHMP), a division of the European Medicines Agency, has recommended approval of insulin lispro 200 units/ml (proposed trade name: Humalog 200 units/ml KwikPen) for the treatment of type 1 and type 2 diabetes in adults.

Humalog 200 units/ml KwikPen is a pre-filled pen which, if approved, will deliver the same amount of insulin with half the volume per injection as the currently marketed Humalog (insulin lispro 100 units/ml) KwikPen. The device holds 600 units of insulin – twice as many as Humalog (insulin lispro 100 units/ml) KwikPen – in the same 3 ml pen size. Humalog 200 units/ml KwikPen is intended for people with diabetes who take more than 20 units of rapid-acting insulin per day.

“Diabetes is a progressive disease, often requiring increased doses of insulin over time to control a patient's blood sugar levels,” said David Kendall, M.D., vice president, Medical Affairs, Lilly Diabetes. “Humalog 200 units/ml KwikPen is the first and only 200 units/ml mealtime insulin and represents an important advancement in the treatment of diabetes.”

A pharmacokinetics/pharmacodynamics study comparing insulin lispro U-200 to Humalog U-100 met the criteria established for bioequivalency, providing support for the same efficacy and safety profile as Humalog U-100. Additionally, there were no adverse events related to study drug observed in the study.

The European Commission typically follows the committee's recommendation and is expected to make its final decision in approximately two months.

About Diabetes

An estimated 382 million people worldwide have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases. Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.

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 are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions – from medicines to support programs and more – we strive to make life better for all those affected by diabetes around the world. 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 http://newsroom.lilly.com/social-channels.

Source: Eli Lilly and Co.

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