A diabetes treatment developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY) has cleared another regulatory hurdle. Trulicity, a non-insulin, injectable medication, has been granted marketing authorization by the European Commission. November 26, 2014

News Release

INDIANAPOLIS, Ind. (November 25, 2014) – Eli Lilly and Company announced today that the European Commission granted marketing authorisation for Trulicity (dulaglutide) solution for injection. Trulicity, a GLP-1 receptor agonist, is a once-weekly, injectable solution designed to improve glycaemic control in adults with type 2 diabetes. The medicine comes in a ready-to-use pen with a pre-attached, hidden needle. Trulicity received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) on 25 September 2014.

“Trulicity's approval in the European Union represents another significant milestone in Lilly's global diabetes programme,” said Jeremy Morgan, vice president, Lilly Diabetes International. “Across the region, diabetes remains a burden on the health system, and we look forward to helping even more patients with type 2 diabetes reach their treatment goals.”

Trulicity is indicated to improve glycaemic control in adults with type 2 diabetes:

in combination with other glucose-lowering medicines, including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control; and as

monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.

Trulicity 1.5 mg once weekly is recommended for those taking Trulicity in combination with other diabetes treatments. Trulicity 0.75 mg once weekly is the recommended dose for patients taking it as monotherapy and can be considered as a starting dose (in combination with other diabetes treatments) for certain vulnerable populations, including patients aged 75 years and older.

The marketing authorisation is based, in part, on results from a number of studies, including six large Phase 3 clinical trials. In the first five trials, Trulicity 1.5 mg was superior to placebo and four commonly used type 2 diabetes medicines in reducing average blood sugar levels (HbA1c). Trulicity 0.75 mg provided similar HbA1c reductions in one of the trials, and demonstrated superiority in the other four. In the sixth trial, Trulicity 1.5 mg showed similar HbA1c reductions to the highest approved dose of a commonly used once-daily GLP-1 receptor agonist.

The most frequently reported adverse events were gastrointestinal-related and, when used in combination with mealtime insulin or metformin plus glimepiride, documented symptomatic hypoglycaemia (low blood sugar). These adverse events are consistent with those seen with other GLP -1 receptor agonists.

Trulicity received approval from the U.S. Food and Drug Administration on 18 Sept. 2014, and has several other pending regulatory applications. Trulicity will be available to patients in Europe in 2015.

About Diabetes

An estimated 387 million people worldwide have type 1 and 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 Trulicity

Trulicity is a once-weekly, glucagon-like peptide-1 (GLP-1) receptor agonist injectable prescription medicine. Trulicity is not insulin. It acts like GLP-1, a natural hormone, helping the body release its own insulin when patients eat.

Trulicity comes in a pen that does not require the patient to mix, measure or handle the needle. It can be taken any time of day, with or without meals, and should be injected subcutaneously in the abdomen, thigh or upper arm.

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, @LillyHealth on Twitter and newsroom.lilly.com/social-channels.


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