Business Wire

U.S. FDA approves Jardiance® (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease

Del

The U.S. Food and Drug Administration (FDA) approved a new indication for Jardiance® (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. Jardiance® is the first type 2 diabetes treatment approved with this additional indication and the only oral type 2 diabetes medicine shown in a clinical trial to provide a life-saving cardiovascular benefit. Jardiance® is marketed by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY).

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161205006066/en/

“As the only diabetes treatment approved by the FDA to reduce the risk of cardiovascular death, Jardiance® represents a tremendous step forward in our efforts to reduce the impact of heart disease among adults with type 2 diabetes and cardiovascular disease,” said Dr Georg van Husen, Corporate Senior Vice President, Head of the Therapeutic Area CardioMetabolism, Boehringer Ingelheim. “This approval is another example of our commitment to the discovery and development of treatment options for adults with type 2 diabetes. We believe that Jardiance® is an important treatment option for this patient population.”

Jardiance® is not for people with type 1 diabetes or people with diabetic ketoacidosis (increased ketones in the blood or urine).

The approval is based on breakthrough evidence from the landmark EMPA-REG OUTCOME® trial, which investigated the effects of Jardiance® compared with placebo when added to standard of care type 2 diabetes and cardiovascular medicines in adults with type 2 diabetes and established cardiovascular disease. In the trial, Jardiance® significantly reduced the risk of the combined primary endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo (HR 0.86, 95% CI: 0.74-0.99); absolute risk reduction was 1.6 percent for Jardiance® versus placebo. This primary finding was driven by a significant 38 percent reduction in the risk of cardiovascular death (HR 0.62, 95% CI: 0.49-0.77); absolute risk reduction was 2.2 percent for patients taking Jardiance® versus placebo. There was no change in the risk of non-fatal heart attack (HR 0.87, 95% CI: 0.70-1.09) or non-fatal stroke (HR 1.24, 95% CI: 0.92-1.67). The cardiovascular benefits of Jardiance® were consistent among patient subgroups.

Adults with type 2 diabetes should not take Jardiance® if they have severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or any ingredient in Jardiance®. Jardiance® can cause dehydration and low blood pressure. Jardiance® can also cause increased ketones in the blood (ketoacidosis), serious urinary tract infection, acute kidney injury and impairment in renal function, low blood glucose when used with insulin or insulin secretagogues (e.g., sulfonylurea, a medication used to treat type 2 diabetes), vaginal yeast infections and yeast infections of the penis, and increased cholesterol.

“People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes. The new indication for empagliflozin enables physicians for the first time to provide adults with type 2 diabetes with a diabetes medication that can reduce their risk of dying from cardiovascular disease,” said Professor Christopher P. Cannon, M.D., Cardiovascular Division, Brigham and Women's Hospital and professor of medicine, Harvard Medical School. “It also gives physicians an opportunity to speak with and educate people with type 2 diabetes about their increased risk for cardiovascular disease and to help them understand this serious complication of their condition.”

“Despite significant medical advances, approximately two out of three people with type 2 diabetes in the US still die from cardiovascular disease. The Boehringer Ingelheim and Lilly Diabetes Alliance is proud to bring a groundbreaking innovation to millions of adults with type 2 diabetes and established cardiovascular disease,” said Enrique Conterno, Senior Vice President and President, Lilly Diabetes. “As part of our ongoing commitment to people with type 2 diabetes, we are also expanding our efforts to educate the public on the link between cardiovascular disease and type 2 diabetes.”

In 2014, Jardiance® was approved by the FDA as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes.

###

About the EMPA-REG OUTCOME ® Trial (NCT01131676)

EMPA-REG OUTCOME® was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients, from 42 countries, with type 2 diabetes and established cardiovascular disease.

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 cardiovascular drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.

Over a median of 3.1 years, Jardiance® significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. Risk of cardiovascular death was reduced by 38 percent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.

The safety profile of Jardiance® in the EMPA-REG OUTCOME® trial was consistent with that of previous trials. The overall incidence of adverse events was similar to placebo.

About Diabetes and Cardiovascular Disease

Approximately 29 million Americans and an estimated 415 million people worldwide have diabetes, and nearly 28 percent of Americans with diabetes—totaling 8 million people—are undiagnosed. In the U.S., approximately 12 percent of those aged 20 and older have diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diagnosed adult diabetes cases in the U.S. Diabetes is a chronic condition that occurs when the body does not properly produce or use the hormone insulin.

Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, cardiovascular 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 cardiovascular disease than people without diabetes. Approximately 50 percent of deaths in people with type 2 diabetes worldwide and 68 percent of deaths in people with type 2 diabetes in the U.S. are caused by cardiovascular disease. In the U.S., health care costs for managing cardiovascular conditions in patients with diabetes totaled more than $23 billion in 2012.

Having diabetes can shorten a person’s lifespan by as much as six years compared with someone without diabetes.* And having both diabetes and a history of heart attack or stroke can shorten a person’s lifespan by as much as 12 years compared with someone without these conditions.**

* Based on having a history of diabetes at age 60.

** Based on having a history of diabetes and heart attack or stroke at age 60.

About Jardiance ®

Jardiance® (empagliflozin) is an oral, once daily, highly selective sodium glucose co-transporter 2 (SGLT2) inhibitor approved for use in Europe, the United States and other markets around the world for the treatment of adults with type 2 diabetes.

Jardiance® works by blocking the reabsorption of glucose (blood sugar) by the kidney, leading to urinary glucose excretion, and lowering blood glucose levels in people with type 2 diabetes. SGLT2 inhibition targets glucose directly and works independently of β-cell function and the insulin pathway.

Jardiance® is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

Intended audiences

This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.

###

Please click on the link below for ‘Notes to Editors’ and ‘References’:

https://www.boehringer-ingelheim.com/press-release/fda-approval-jardiance-cv-label

Contact information

Boehringer Ingelheim
Dr Petra Kienle
Product Communications Manager
Email: petra.kienle@boehringer-ingelheim.com
Phone: +49 (6132) 77 143877
or
Lilly Diabetes
Molly McCully
Communications Manager
Email: mccully_molly@lilly.com
Phone: +1 (317) 478 5423

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Pierre Fabre & Array BioPharma Announce a 62% Observed OS at One Year from the Phase 3 BEACON CRC Safety Lead-In of the Combination of Encorafenib, Binimetinib and Cetuximab in BRAF-Mutant CRC at the ESMO GI Congress23.6.2018 11:00Pressemelding

Not intended for UK- and US-based media Pierre Fabre and its partner Array BioPharma Inc. today announced updated safety and efficacy results, including OS, from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF V600E -mutant metastatic colorectal cancer (CRC). The results showed that, at the time of analysis, the OS data were fully mature through 12.6 months and that the median OS had not yet been reached. The one-year overall survival rate for this cohort was 62%. These data were presented in an oral presentation on Saturday, June 23, at the ESMO 20th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The median progression-free survival (mPFS) for patients treated with the triplet was 8 months [95% CI 5.6-9.3] and is similar between patients receiving one prior line of therapy and patients receiving two prior lines

Compelling Data for LONSURF® (trifluridine/tipiracil) in Metastatic Colorectal Cancer Presented at ESMO’s World Congress on Gastrointestinal Cancer by Servier and Taiho23.6.2018 08:10Pressemelding

Servier and Taiho Pharmaceutical Co., Ltd. today announced that the TASCO-1 trial demonstrated promising results for LONSURF® (trifluridine/tipiracil) in combination with bevacizumab in patients with previously untreated metastatic colorectal cancer (mCRC) who are not suitable for intensive treatment, with a median progression-free survival (PFS) of 9.2 months (ranging from 7.6 to 11.5 months). A second non-comparative arm in the trial, evaluated the outcome of patients treated with the current standard of care of capecitabine in combination with bevacizumab. The median PFS of this arm was 7.8 months (ranging from 5.5 to 10.1 months). “Colorectal cancer is the third most common cancer in the world. While there has been some progress in treatment, there are still few options for patients with metastatic disease who are not suitable for intensive treatment,” said Professor Eric Van Cutsem, Head of Digestive Oncology at the University of Leuven, Belgium. “These compelling results suggest

Softomotive and Accelerate RPA Partner to Help Enterprises Achieve Faster Time to Value from RPA22.6.2018 15:13Pressemelding

Softomotive, a world–class Robotic Process Automation (RPA) technology provider offering best time to value and affordability for all sizes and types of enterprises, is pleased to announce a strategic partnership with AccelerateRPA, a high calibre professional services provider of trained and certified RPA Consultants within Robotic Process Automation. This partnership means that customers and end users of Softomotive’s software, will have additional knowledgeable and professional guidance available to help achieve significant value quickly from their investment in RPA. Companies who are looking to implement Softomotive’s RPA product suite (WinAutomation and ProcessRobot software) will now have direct access to AccelerateRPA’s highly skilled consultants and Developers. Further, AccelerateRPA has also become a licensed reseller of Softomotive’s products, offering customers a single point of contact for delivering both RPA software and services. Ashley Hudson, Director of AccelerateRPA,

Ascend Performance Materials Announces Price Increase for Intermediate Materials22.6.2018 14:00Pressemelding

Ascend Performance Materials announced today a price increase for its intermediate materials. The price increase will take effect globally on July 1, 2018, and includes the following terms: Material Price Increase Terms Hexamethylene diamine (HMD) $0.17/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Acrylonitrile (AN) $0.20/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Customers should contact their local sales representative for additional information. About Ascend Performance Materials Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals and is the world’s largest integrated producer of PA66 resin. Headquartered in Houston, Texas, Ascend has eight global locations, including five fully-integrated manufacturing facilities located in the southeastern United States, all dedicated to the innovation and safe production of nylon 6,6. With

Different Countries, Different Customs: Get Ready for the Motorbike Holidays with Moto-tyres.co.uk22.6.2018 13:41Pressemelding

Pack your bags, close the boot and get away on holiday? When you start your holidays on a motorcycle, you usually have to consider a few things more when getting ready for your trip. The right preparation is therefore a must. So that nothing stands in the way of a smooth journey, Moto-tyres.co.uk has put together some tips for your next trip. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005345/en/ Different countries, different customs: get ready for the motorbike holidays with Moto-tyres.co.uk (Photo: Business Wire) Whether a weekend trip or extended adventure, it all depends on the right equipment. Functional clothing, protectors and rain protection are a must on long trips. Wearing a suitable motorcycle helmet is a legal requirement almost everywhere. However, there are also very different rules and regulations for motorbike equipment and accessories depending on the destination, and you should familiarise yoursel

Boehringer Ingelheim bolsters biologics research and development with 230 million euro investment in new development center22.6.2018 12:00Pressemelding

Today Boehringer Ingelheim announced a 230 million euro investment into a new Biologicals Development Center (BDC) at the company’s Research and Development site in Biberach, Germany during the foundation stone laying for the new center. “The BDC is another key building block supporting the company’s long-term strategy for increasing the pipeline’s share of biologicals. This is particularly driven by two of our core areas, immune oncology and immunology,” says Dr. Fridtjof Traulsen, Corporate Senior Vice President Development at Boehringer Ingelheim. “The share of new biological entities in Boehringer Ingelheim’s research pipeline has been consistently increasing over the past few years and has now reached forty percent.” The BDC will help to maximize synergies by integrating biologicals analytical and process development as well as manufacturing for clinical studies into one seamless unit, while at the same time increasing development capacity. Following a staggered launch beginning i