-- If approved, Lilly's GLP-1 receptor agonistwill provide type 2 diabetes patients a once-weekly treatment option in a single-dose, ready-to-use pen
INDIANAPOLIS, Sept. 26, 2014 /PRNewswire/ -- The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Trulicity() (dulaglutide) solution for injection in the European Union. If approved, Trulicity will be indicated to improve glycaemic control in adults with type 2 diabetes as monotherapy or in combination with other diabetes medicines, including insulin. Trulicity will be offered to patients in a ready-to-use pen with a pre-attached, hidden needle.
"The CHMP positive recommendation of Trulicity, discovered in Lilly labs and designed with the patient in mind, further strengthens Lilly's longstanding commitment to diabetes and improving quality of life for patients," said Dr. David Kendall, vice president, Medical Affairs, Lilly Diabetes. "If approved in the European Union, Trulicity, with its ready-to-use pen, will be an important treatment option for type 2 diabetes and for patients making the transition to their first injectable therapy. "
The positive opinion 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.
If approved, Trulicity will be provided to patients in a ready-to-use, pre-filled pen with a needle that inserts with the push of a button and automatically retracts - there's no need to see or handle the needle during self-administration. The recommended dose will be 1.5 mg once weekly 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 for certain vulnerable populations, including patients aged 75 years and older.
The European Commission typically follows the CHMP's recommendation. A final decision is expected in approximately two months. Trulicity received approval from the U.S. Food and Drug Administration on Sept. 18, 2014, and has several other pending regulatory applications.
About DiabetesAn estimated 382 million people worldwide have type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 85 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.(1)
About Lilly DiabetesLilly 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 [http://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 [http://www.lilly.com/], @LillyHealth on Twitter and http://newsroom.lilly.com/social-channels [http://newsroom.lilly.com/social-channels].
This press release contains forward-looking statements about dulaglutide that are based on Lilly's current expectations. Actual results could differ materially from these expectations. There are significant risks and uncertainties in the process of drug development and commercialization. There can be no guarantee that future study results and patient experience will be consistent with the study findings to date. There can also be no guarantee that dulaglutide will be approved by regulatory authorities or that it will prove to be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see the company's latest Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Except as required by law, the company undertakes no duty to update forward-looking statements.
(1 )International Diabetes Federation. IDF Diabetes Atlas, 6th edn. Brussels, Belgium: International Diabetes Federation, 2013. http://www.idf.org/diabetesatlas [http://www.idf.org/diabetesatlas].
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Refer to: Candace Johnson, +1-317-755-9143, johnson_candace_a@lilly.com[mailto:johnson_candace_a@lilly.com]
