Type 2 diabetes: European Commission approves Jardiance® (empagliflozin) tablets for use in adults in Europe
JARDIANCE is a member of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney.
"In Europe, the number of people with type 2 diabetes is growing and management of the condition increasingly requires a holistic approach for individuals and their needs," said Professor
The marketing authorization is based on results from a clinical program comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D. Phase III studies showed JARDIANCE 10 and 25 mg significantly reduced hemoglobin A1c (A1c, or average blood glucose) as well as body weight and blood pressure as a stand-alone treatment or in combination with a range of background treatments, including metformin, sulfonylureas, insulin and pioglitazone.1 The most frequently reported adverse reaction was hypoglycemia when used with sulfonylurea or insulin.1 Common side effects experienced with JARDIANCE were genital infection, urinary tract infection, pruritus and increased urination. Genital infection and urinary tract infection were more common in women than men.1 JARDIANCE is not indicated for weight loss or as antihypertensive therapy. Weight loss and blood pressure change were secondary or exploratory endpoints in clinical trials.
"The approval of empagliflozin marks the third diabetes product from the Boehringer Ingelheim and Lilly Diabetes alliance to be approved in
Approximately 24.4 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes. T2D is the most common type, accounting for an estimated 85 to 95 percent of all diabetes cases. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin. 2
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The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim,
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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.
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.
This press release contains forward-looking statements about empagliflozin, an investigational compound that is being studied for type 2 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 empagliflozin will receive regulatory approvals or prove to 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
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1 Jardiance® (empagliflozin) tablets. EMA Summary of Product Characteristics. Approval May 2014.
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