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FDA Advisory Committee recommends approval of Jardiance® (empagliflozin) for cardiovascular indication in 12-11 vote | ||
By: PR Newswire Association LLC. - 29 Jun 2016 | Back to overview list |
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RIDGEFIELD, Conn. and INDIANAPOLIS, June 28, 2016 /PRNewswire/ -- A U.S. Food and Drug Administration (FDA) Advisory Committee today voted 12-11 that substantial evidence exists to establish that Jardiance® (empagliflozin) reduces cardiovascular (CV) death in adults with type 2 diabetes (T2D) and established CV disease. JARDIANCE, which is marketed by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), is the only oral T2D medicine shown in a clinical trial to reduce the risk of CV death. "Today's robust discussion and resulting vote are important as we look to gain approval of a new indication for JARDIANCE as the first type 2 diabetes treatment to provide a cardiovascular benefit," said Thomas Seck, M.D., vice president, Clinical Development and Medical Affairs – Metabolism, Boehringer Ingelheim Pharmaceutical, Inc. "We look forward to continuing to work with the FDA in our ongoing efforts to provide options that help reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease." The recommendation was made by the Endocrinologic and Metabolic Drugs Advisory Committee based on data from the landmark EMPA-REG OUTCOME® trial, which found that JARDIANCE significantly reduced the risk of the combined endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14 percent when added to standard of care in adults with T2D and established CV disease. The primary finding was driven by a 38 percent reduction in CV death, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. The overall safety profile of JARDIANCE was consistent with that of previous trials. "Despite significant advances in the prevention and treatment of cardiovascular disease over the past several decades, more than half of adults with type 2 diabetes worldwide still die due to cardiovascular causes," said Jeff Emmick, M.D., Ph.D., vice president, product development, Lilly Diabetes. "The cardioprotective profile of JARDIANCE could provide an additional option to physicians to reduce the risk of cardiovascular death in their patients with type 2 diabetes." About the EMPA-REG OUTCOME Trial (NCT01131676) The study assessed the effect of JARDIANCE (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and CV drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke. Over a median of 3.1 years, JARDIANCE significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. Risk of CV death was reduced by 38 percent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. The overall safety profile of JARDIANCE in the EMPA-REG OUTCOME trial was consistent with that of previous trials. About Diabetes and Cardiovascular Disease Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, CV disease is a major complication and the leading cause of death associated with diabetes. People with diabetes are two to four times more likely to develop CV disease than people without diabetes. In 2015, diabetes caused 5 million deaths worldwide, with CV disease as the leading cause. Approximately 50 percent of deaths in people with T2D worldwide are caused by CV disease. In the U.S., health care costs for managing CV conditions in patients with diabetes totaled more than $23 billion dollars in 2012. What is JARDIANCE? JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). IMPORTANT SAFETY INFORMATION What is the most important information I should know about JARDIANCE? JARDIANCE can cause serious side effects, including:
You may be at a higher risk of dehydration if you:
Who should not take JARDIANCE? Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE. Symptoms of serious allergic reactions to JARDIANCE may include:
If you have any of these symptoms, stop taking JARDIANCE and contact your doctor or go to the nearest emergency room right away. Do not take JARDIANCE if you have severe kidney problems or are on dialysis. What should I tell my doctor before using JARDIANCE? Tell your doctor if you:
Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take water pills (diuretics) or medicines that can lower your blood sugar such as insulin. What are other possible side effects of JARDIANCE?
The most common side effects of JARDIANCE include urinary tract infections, and yeast infections in females. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For more information, please see full Prescribing Information, including Patient Information. JAR CONS ISI 12.8.15 Boehringer Ingelheim and Eli Lilly and Company About Boehringer Ingelheim Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine. Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report. In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion dollars (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales. For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS. About Lilly Diabetes About Eli Lilly and Company This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about JARDIANCE as a treatment of adults with type 2 diabetes and established CV disease, and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that JARDIANCE will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Jardiance® and EMPA-REG OUTCOME® are registered trademarks of Boehringer Ingelheim. P-LLY PC-JAR-0016-PR CONTACT: Jennifer Forsyth Molly McCully
Logo - http://photos.prnewswire.com/prnh/20031219/LLYLOGO Logo - http://photos.prnewswire.com/prnh/20110825/DE57898LOGO SOURCE Eli Lilly and Company; Boehringer Ingelheim |
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