Business Wire

CHMP issues positive opinion to expand Jardiance®, Synjardy® and Glyxambi® labels to include positive effects on cardiovascular and renal outcomes

Jaa

Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to update the labels of Jardiance® (empagliflozin), Synjardy® (empagliflozin and metformin) and Glyxambi® (empagliflozin and linagliptin) to include additional important data from the landmark EMPA-REG OUTCOME® trial on heart failure and kidney endpoints.1,2,3,4

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180702005331/en/

The labels now include additional results from the EMPA-REG OUTCOME® trial, specifically a relative risk reduction in hospitalisation for heart failure by 35 percent and a relative risk reduction for new-onset or worsening of kidney disease by 39 percent with empagliflozin, compared with placebo, in people with type 2 diabetes and established cardiovascular disease.1,2,3,4,5

“Heart failure and kidney disease are highly prevalent in people with type 2 diabetes and are associated with high morbidity and mortality,” commented Dr Waheed Jamal, Corporate Vice President, Head of CardioMetabolic Medicine, Boehringer Ingelheim. “Due to the current unmet medical need to treat these conditions, we are pleased that the European Medicines Agency has recognised the demonstrated benefits of empagliflozin to reduce the risks of heart failure and kidney disease in people with type 2 diabetes and established cardiovascular disease.”

“In the EMPA-REG OUTCOME® trial, empagliflozin demonstrated superiority in reducing the risk of cardiovascular death in people with type 2 diabetes and established cardiovascular disease,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly Diabetes. “As a result, empagliflozin was the first type 2 diabetes treatment to have either a cardiovascular indication or data on the reduction of the risk of cardiovascular death included in the label.”

Based on results from the EMPA-REG OUTCOME® trial, Boehringer Ingelheim and Eli Lilly and Company are further investigating empagliflozin in people with heart failure (EMPEROR and EMPERIAL clinical trials) and chronic kidney disease (EMPA-KIDNEY clinical trial), both with and without diabetes.6,7,8,9

About EMPA-REG OUTCOME ®4,5

EMPA-REG OUTCOME® is a long-term, multinational, randomised, double-blind, placebo-controlled clinical trial of more than 7,000 people from 42 countries with type 2 diabetes and established cardiovascular disease.

The study assessed the effect of empagliflozin (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.

The overall safety profile of empagliflozin in the EMPA-REG OUTCOME® trial was consistent with that of previous trials.

About Heart Failure

Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot pump enough blood around the body.10 Symptoms of heart failure include difficulty breathing, swelling, and fatigue amongst others.11 Heart failure is a prevalent disease; 26 million people around the world have chronic heart failure.12 There is a high unmet need in the treatment of heart failure, as approximately 50 percent of people diagnosed with heart failure will die within five years.13 Additionally, heart failure represents the most common cause of hospitalisation among individuals aged 65 years and over in the United States and Europe.12 Heart failure is highly prevalent in people with diabetes;14 however, approximately half of all people with heart failure do not have diabetes.12,15

About Chronic Kidney Disease

Chronic kidney disease is defined as a progressive decline of kidney function over time. About two thirds of chronic kidney disease cases are attributable to metabolic conditions such as diabetes, obesity and hypertension.16,17,18

Notably, chronic kidney disease is associated with increased morbidity and mortality. The majority of deaths among people with chronic kidney disease occur as a result of cardiovascular complications, often before reaching end stage kidney disease.19,20,21 Once end stage kidney disease is reached, affected individuals have to undergo kidney replacement treatments, such as chronic dialysis or kidney transplantation.22 Chronic kidney disease is highly prevalent in various parts of the world, affecting more than 10 percent of the population.23 Since there is currently no approved treatment available to specifically reduce kidney disease progression and cardiovascular death, the overarching unmet medical need for new treatment options in people with chronic kidney disease is evident.

About Empagliflozin

Empagliflozin (marketed as Jardiance®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include data on the reduction of the risk of cardiovascular death in the label.24,25,26

Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels leads to excretion of excess sugar in the urine. In addition, initiation of empagliflozin increases excretion of salt from the body and reduces the fluid load of the body’s blood vessel system (i.e. intravascular volume). Empagliflozin induces changes to the sugar, salt and water metabolism in the body that may contribute to the reductions in cardiovascular death observed in the EMPA-REG OUTCOME® trial.

Please click on the following link for ‘Notes to Editors’ and ‘References’: https://www.boehringer-ingelheim.com/press-release/chmp-positive-opinion

Contact information

Dr Petra Kienle
Product Communication Manager
Boehringer Ingelheim
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 143877
or
Grant Smith
Manager, Global Business Communications
Eli Lilly and Company
Email: grant.smith@lilly.com
Phone: +1 (317) 954-9907

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Bearingpoint Acquires Inpuls, a Leading Data Specialist in Belgium14.11.2018 12:20Tiedote

Management and technology consultancy BearingPoint has made a strategic move in the Belgian consulting market by acquiring Inpuls, a leading data specialist. The acquisition contributes to BearingPoint’s overall growth objectives, strengthens its presence in Belgium, and enhances its data capabilities. “The acquisition of Inpuls pays into two core elements of our corporate strategy: we enrich our portfolio focused on digitalization, regulation, and analytics; we concentrate on European clients, enabling them to become global leaders. Against this background this acquisition doubles our size in Belgium, and just as important, our clients now have Inpuls’s data expertise. We believe data is at the heart of digital transformation and creates value propositions and competitive advantages for our clients,” said Kiumars Hamidian, Managing Partner of BearingPoint. Founded in 2014, Inpuls is a Belgian consultancy specialized in data strategy, data governance, privacy, Big Data, and analytics.

GSMA Announces New Developments for MWC19 Barcelona14.11.2018 12:00Tiedote

The GSMA today announced further details for MWC19 Barcelona (formerly Mobile World Congress), including additional keynote speakers, participating companies, programmes and events. Taking place 25-28 February 2019, with events being staged at Fira Gran Via, Fira Montjuïc and La Farga L’Hospitalet, MWC19 Barcelona is set to attract more than 107,000 professionals from over 200 countries and territories. “We have an amazing show lined up for February, with more than 2,400 companies participating across the exhibition, four days of conference programming and so many other events and activities taking place at MWC19,” said Michael O’Hara, Chief Marketing Officer, GSMA. “With in-depth examination of topics such as 5G, artificial intelligence, Internet of Things, content, security and many others, MWC Barcelona, now more than ever, is the “must-attend” industry event.” Execs from ARM, Huawei, KT and Orange Confirmed for Keynotes The GSMA announced several newly confirmed keynote speakers fo

Exclusive Group and Arcitura Education Team Up for Channel Partners to Profit from Cloud Skills Gap14.11.2018 11:00Tiedote

Exclusive Group, the value-added services and technologies (VAST) group, today announced an agreement to become the only global provider of Arcitura Education’s renowned, vendor-neutral Cloud Certified Professional (CCP) accreditation programme. The move underlines the unique value of Exclusive Group’s ‘Cloud Competency Centre’ and will enable thousands more channel partners to develop the skills necessary to meet evolving customer challenges around cloud transformation and convert significant additional revenues. “Channel partners can’t afford to lose their market edge through a lack of cloud competency – they need new skills to complement their experience and technology knowledge so that customers carry on seeing them as relevant to their future,” said Andre Dieball, Global Director, Services at Exclusive Group. “70-80% of enterprises are experiencing cloud skills crises that risk crucial transformation projects going over time and over budget. These projects, collectively worth bill

Kenetic Bucks Crypto Market Trend with YTD 77% Returns in Investment Portfolio14.11.2018 10:37Tiedote

Kenetic, a blockchain investment and advisory firm based in Hong Kong, has revealed that its proprietary investment portfolio has recorded year-to-date returns of 77 percent as of October 31, 2018, against a backdrop of major losses in the cryptocurrency market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181113006323/en/ After hitting its record high in December 2017, Bitcoin has fallen over 50 percent in 2018 and the overall crypto market is down around 65%. Kenetic’s proprietary investment portfolio is comprised of its best ideas that have undergone thorough due diligence by its experienced investment team. Its alpha-generating strategies are largely focused on early stage investments, catalyst driven events and macro themes, complemented by prudent risk management and proprietary in-house trading tools. “As active leaders in the global blockchain community, we see where the strongest investment opportunities lie and r

Smiths Detection State-of-the-Art Checkpoint Lanes Chosen for Israeli Airports14.11.2018 10:30Tiedote

Smiths Detection and its local distributor, Eastronics, have been selected by the Israel Airport Authority (IAA) to supply 32 advanced checkpoint lanes for Ben Gurion Airport and the new Ramon International Airport, which is due to open in 2019. These latest, highly functional lane designs from Smiths Detection incorporate automated tray return and diversion and were developed to improve operational efficiency and passenger experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181113005810/en/ “Automation plays a key role in streamlining screening by literally keeping things moving and the result is increased throughput, lower per capita costs and a passenger friendly process,” explained Tony Tielen, Vice President EMEA, at Smiths Detection. “With the help of Eastronics, we were delighted to be able to meet IAA’s stringent requirements for this extensive project, which could have a significant impact on maintaining flow

CHTF 2018 Opens, Gathering Global Enterprises and Entrepreneurs14.11.2018 09:00Tiedote

The 20th China Hi-Tech Fair (CHTF 2018) kicked off at the Shenzhen Convention and Exhibition Center on November 14, 2018. By showcasing cutting-edge high-tech products and technologies of enterprises and institutions from around the world, CHTF 2018 remained a trend setter in the high-tech industry. A large number of technology companies have emerged from CHTF in the past two decades. In its 20th year, CHTF 2018 attracted the world's top experts and scholars, and gathered multinational corporations, Fortune 500 companies and unicorn enterprises to showcase the latest technical developments. Chinese giants included China Mobile, China Unicom, China Telecom, China Electronics, CRRC; multinational companies included Suez, Foxconn, Ricoh, Baidu, Tsinghua Tongfang, TCL, Sogou, BOE; unicorn enterprises included SenseTime, iQiyi, Royale, Orbbec, Qiniu Cloud, BITMAIN, etc. In addition, three leading AI chip companies, namely Cambrian, Horizon Robotics and Deephi Tech, were also involved. The C

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme