Business Wire

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

Del

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

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

Ipsen Receives Positive CHMP Opinion for Cabometyx® (Cabozantinib) for the Second-line Treatment of Patients with Hepatocellular Carcinoma (HCC)21.9.2018 05:30Pressemelding

Regulatory News: Ipsen (Euronext:IPN; ADR:IPSEY) announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), provided a positive opinion for Cabometyx® (cabozantinib) as a monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have been previously treated with sorafenib. The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Alexandre Lebeaut, MD, Executive Vice President, R&D and Chief Scientific Officer, Ipsen, said: “The global burden of liver cancer is increasing and despite the recent introduction of new agents, it remains the second leading cause of cancer mortality worldwide. Following today’s positive CHMP opinion and if approved by the European Commission, Cabometyx ® as monotherapy will give patients with HCC a much-needed new oral therapeutic option.” Dr Lorenza Rimassa,

Quanergy Selected as Exclusive LiDAR Partner for VRCO21.9.2018 05:00Pressemelding

Quanergy Systems, Inc., a global leader in the design and development of solid state LiDAR sensors and smart sensing solutions, and VRCO, designer and manufacturer of the luxury high-end e-VTOL (electric Vertical Take-Off and Landing) craft, the NeoXcraft XP2, today announced that VRCO will exclusively use Quanergy’s S3 solid state LiDAR sensors in the testing and market release versions of the aircraft. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920006036/en/ VRCO NeoXcraft XP2 with Quanergy S3 LiDAR Sensor (Graphic: Business Wire) The NeoXcraft XP2, which VRCO and the University of Derby unveiled in late 2017 and intend to launch in 2020, is a two-passenger e-VTOL high-speed land, air, and water capable craft. The craft can scan and memorize take-off locations and store the data for use on the next approach to the same location. Quanergy’s innovative S3 solid state LiDAR sensor will be used for downward and forward

Overseas Roadshow for the IAPH Guangzhou 2019 World Ports Conference Was Held in London21.9.2018 03:08Pressemelding

Overseas roadshow for the IAPH Guangzhou 2019 World Ports Conference was successfully held in Armourer's Hall, London, UK on September 20th. Ms. Yuan Yue, Deputy Director General of Guangzhou Port Authority, met with over 100 senior representatives from British ports, ship-owners, commodity traders, shipping & service companies, shipping public policy research institutes, and other representatives from the port and shipping industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920006031/en/ Speech made by Lord Jeffrey Evans, Chairman of Maritime London (Photo: Business Wire) In her keynote speech, Ms. Yuan Yue said, “Guangzhou is the gateway city of South China and is known as the “Millennium Business Capital” and a popular destination for business and investment. At present, Guangzhou has attracted investors from over 130 countries. Nearly 300 of the world's top 500 companies have businesses and investment in Guangzho

AbuDhabi Dubai STOB Series 22 Investment Enters into Favorable Tender Offer Agreement with MINDOL HOLDINGS21.9.2018 01:00Pressemelding

AbuDhabi Dubai STOB Series 22 Investment Limited Partnership, hereafter AbuDhabi22, and MINDOL HOLDINGS LIMITED, hereafter MINDOL, listed on the Hong Kong-based Coinsuper exchange (https://www.coinsuper.com) have reached an agreement where AbuDhabi22 will acquire the minimum 33.3 percent holding for the MINDOL cryptocurrency (MIN, https://mindol.net) to be issued by MINDOL, via a tender offer (TOB). Implementation of the TOB will serve to strengthen the strategic partnership with MINDOL. Both companies expect that the AbuDhabi22 bid will greatly exceed any bids made via ordinary exchange channels. With a bid offering at a stable price, the TOB method was chosen for its strategic worth. The MINDOL business vision for 2019 sets a target for its cryptocurrency, from among the more than 2,000 types of cryptocurrencies currently available, to have a top-30 market capitalization. As a business that focuses on "the fusion of subculture and blockchain," they will develop an online game that ta

Afton Chemical’s S$380 Million Phase II Expansion of Its Jurong Island Plant is Now Complete20.9.2018 21:07Pressemelding

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 20:15Pressemelding

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