CHMP issues positive opinion to expand Jardiance®, Synjardy® and Glyxambi® labels to include positive effects on cardiovascular and renal outcomes
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.
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
Dr Petra Kienle
Product Communication Manager
Phone: +49 (6132) 77 143877
Manager, Global Business Communications
Eli Lilly and Company
Phone: +1 (317) 954-9907
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
Afton Chemical’s S$380 Million Phase II Expansion of Its Jurong Island Plant is Now Complete20.9.2018 23:30 | Tiedote
Afton Chemical Corporation, a global leader in the lubricant and fuel additive market, today announced the completion of the Phase II expansion of its Chemical Additive Manufacturing Facility in Jurong Island, Singapore. This milestone was marked by a special visit from Singapore’s Minister for Trade & Industry Mr. Chan Chun Sing, who also made a speech and toured the facility. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920005903/en/ Afton Chemical Corporation – Singapore Chemical Additive Manufacturing Facility Phase II Expansion (Photo: Business Wire) As a wholly owned subsidiary of NewMarket Corporation (NYSE: NEU), Afton has been a leading player in the lubricant and fuel additive marketplace for over 90 years. The company was founded on a Passion for Solutions® and has maintained a focus on customizing commercial and industrial solutions that meet customer needs. Afton begun its Singapore manufacturing operations
IFF Announces Pricing of €1,100,000,000 Senior Notes Offering20.9.2018 23:15 | Tiedote
Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF), a leading innovator of sensorial experiences that move the world, today announced that it has priced its public offering of €300,000,000 aggregate principal amount of its 0.500% senior notes due 2021 and €800,000,000 aggregate principal amount of its 1.800% senior notes due 2026. IFF intends to use the net proceeds from the offering to pay a portion of the consideration for the previously announced merger with Frutarom Industries Ltd. and to pay related fees and expenses. IFF anticipates that the offering will close on September 25, 2018, subject to customary closing conditions. The offering is not contingent upon the consummation of the merger. If the closing of the merger has not occurred on or prior to February 7, 2019, or, if prior to such date, the merger agreement with Frutarom is terminated, IFF will be required to redeem all of the notes on the special mandatory redemption date at a redem
Pierre Fabre Receives EU Approval for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) in Adult Patients with Advanced BRAF-Mutant Melanoma20.9.2018 20:21 | Tiedote
Pierre Fabre today announced that the European Commission (EC) has granted marketing authorisation for the combination of BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.1,2 The EC decision is applicable to all 28 European Union (EU) member states plus Liechtenstein, Iceland and Norway. "We are extremely pleased that European patients with advanced BRAF-mutant melanoma will now have the combination of BRAFTOVI and MEKTOVI as a new treatment option”, said Frédéric Duchesne, President & CEO of the Pierre Fabre Pharmaceuticals Division. “All of us at Pierre Fabre are driven to make a real difference for patients. Bringing more than 30 years of oncology experience and our heritage in dermatology to our partnership with Array BioPharma, we have been able to harness our expertise in order to help men and women living with this devastating disease. Today’s
Clothesource Report Shows Retail Sales Aren’t Falling or Moving Online: Management’s Let Itself Get Misguided20.9.2018 20:19 | Tiedote
According to a new Clothesource report, “The Emperors’ Clothes” retail sales aren’t falling, and they’re not leaving physical stores. Both the UK’s Office of National Statistics and the US Bureau of the Census report higher retail sales than ever – with sales in physical stores still growing every year. Retailers just need to rely on their own customer understanding, recapture their self-confidence, and rediscover their traditional frugality. Among recent front-page stories have been Sears in the US hinting it’s about to go under and profits at Britain’s John Lewis falling 99%. But the well run clothing retailers are prospering. Primark goes from strength to strength: the biggest clothing specialists on either side of the Atlantic (Inditex and TJX) have just upped their sales and profit forecasts. So it’s not about consumer purchasing: The main problem lies with management, says Clothesource CEO Mike Flanagan in a new report “The Emperors’ Clothes”. They’ve lost touch with their custom
BCW Names Latin America Market Leaders20.9.2018 19:23 | Tiedote
BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced the appointment of market leaders in Latin America who will be responsible for business growth, client satisfaction and talent development. All market leaders report to Francisco Carvalho, President, Latin America, BCW. “BCW has a dominant presence in Latin America, thanks to Burson-Marsteller’s 40-year-history and expansive footprint across the region and Cohn & Wolfe’s strength in Brazil and Mexico,” said Carvalho. “This team has unmatched market knowledge, strong client relationships and deep commitment to talent, all of which is critical for our continued success in the region. Those strengths, together with our industry-leading expertise in delivering digitally driven integrated communications programs, make BCW a powerful partner for our clients.” All of BCW’s Latin America market leaders have been drawn from the legacy Burson-Marsteller organization and had been leading their respective markets, e
NavVis Achieves Breakthough 6D SLAM Indoor LiDAR Mapping With Velodyne’s 3D LiDAR Sensor20.9.2018 17:43 | Tiedote
On April 18th, 2018, NavVis released their M6, a fully-integrated, cart-based system designed for large-scale indoor mapping. The M6 utilizes VLP-16 sensors by Velodyne LiDAR, Inc., which allows it to produce a 3D map of the surrounding environment. Six cameras capture 360° immersive imagery and photorealistic point-clouds, resulting in high-resolution mapped images. NavVis developed this product in response to their customers’ request for a more versatile and sophisticated system which could be used effectively with uneven terrain. In addition to AEC professionals, construction companies and manufacturers can also draw benefits from the higher data quality provided by this enhanced innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920005560/en/ NavVis M6 is a fully-integrated, cart-based system designed for large-scale indoor mapping. (Photo: Business Wire) The M6 was developed by NavVis after customers requeste
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