Business Wire

CHMP adopts a positive opinion acknowledging that Jardiance® reduces the risk of CV death

Del

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) today adopted a positive opinion to update the Jardiance® (empagliflozin) label including a change to the indication statement. The CHMP recommends Jardiance® for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2D) as an adjunct to diet and exercise. The recommended product information now includes data on the reduction of risk of cardiovascular (CV) death in patients with T2D and established CV disease in addition to data on the improvement of blood sugar control in patients with T2D. Jardiance® is the only oral diabetes treatment shown to reduce the risk of CV death in a dedicated CV outcome trial to date.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161216005390/en/

The positive opinion is based on results from the EMPA-REG OUTCOME® trial. The trial demonstrated that Jardiance® significantly reduced the risk of the primary endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo when added to standard of care in adults with T2D and established CV disease. Taking Jardiance® on top of standard of care reduced the risk of dying from CV disease by 38 percent. There were no statistically significant differences in the risk of non-fatal heart attack or non-fatal stroke.

“Cardiovascular disease is the number one cause of death among people with type 2 diabetes. The life expectancy of people with type 2 diabetes and cardiovascular disease is up to 12 years shorter. There is a significant need for therapies which add to and go beyond the current standard of care,” said Professor Hans-Juergen Woerle, Global Vice President Medicine, Therapeutic Area Metabolism, Boehringer Ingelheim. “Therefore, this recommendation by the CHMP is an important step towards addressing and reducing the burden of cardiovascular mortality for people with type 2 diabetes.”

On December 2, the U.S. Food and Drug Administration (FDA) approved a new indication for Jardiance® to reduce the risk of CV death in adults with T2D and established CV disease.

###

About the EMPA-REG OUTCOME ® Trial

EMPA-REG OUTCOME® was a long-term, multicentre, randomised, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with T2D and established CV 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 sugar-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. The 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

More than 415 million people worldwide have diabetes, of which 193 million are estimated to be undiagnosed. By 2040, the number of people with diabetes is expected to rise to 642 million people worldwide. T2D is the most common form of diabetes, responsible for up to 91 percent of diabetes cases in high-income countries. Diabetes is a chronic condition that occurs when the body either 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, 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.

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 T2D.

Inhibition of SGLT2 with Jardiance® (empagliflozin) in patients with T2D and high blood sugar levels leads to excretion of excess sugar in the urine. In addition, initiation of Jardiance® increases excretion of salt from the body (i.e. sodium) and reduces the fluid load of the body’s blood vessel system (i.e. intravascular volume). Excretion of sugar, salt and water after the initiation of treatment with empagliflozin may therefore contribute to the improvement in CV outcomes.

The change to the existing indication adopted by the CHMP is as follows:

Jardiance® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

  • as monotherapy when metformin is considered inappropriate due to intolerance
  • in addition to other medicinal products for the treatment of diabetes

For study results with respect to combinations, effects on glycaemic control and CV events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Jardiance® is not approved for patients with type 1 diabetes or for the treatment of 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’:

http://www.boehringer-ingelheim.com/press-release/CHMP-positive-opinion-Jardiance-reduces-risk-of-cv-death

Contact information

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

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

AGCO Announces a New Data Connection with The Climate Corporation’s Climate FieldViewTM Digital Agriculture Platform19.10.2017 14:30Pressemelding

AGCO Corporation (NYSE:AGCO), a world-leading manufacturer and distributor of agricultural equipment, announced today a new digital partnership with The Climate Corporation, a subsidiary of Monsanto Company (NYSE:MON), that will provide AGCO customers the option to connect with The Climate Corporation’s Climate FieldView™ platform. AGCO’s partnership with The Climate Corporation is a product of Fuse and its open approach to agriculture, which focuses on helping customers optimize their farms through seamless technology integration and connectivity. “AGCO is excited to work with The Climate Corporation to give our customers yet another choice for Precision Ag solutions,” says Chris Rhodes, director Fuse Business Development. “The Climate FieldView platform is the world’s most broadly connected and adopted farm insight and visualization platform, and AGCO is pleased to be creating a tigh

Arrive Safely: Head to Tirendo and Equip Yourself Properly for Your First Winter19.10.2017 14:25Pressemelding

The days are getting shorter, and the thermometer is dropping. Especially for new drivers looking forward to their first winter behind the wheel, the sudden onset of snowy and icy roads can be a real challenge. Even more important, therefore, to make sure that you have the appropriate tyres for wintry driving conditions. Tirendo shares some tips on what this involves. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171019005888/en/ Head to Tirendo and equip yourself properly for your first winter - Photo source: ENZO In winter weather above all, the correct tread depth is crucial for safe driving. The legal minimum throughout Europe is 1.6 mm, however experts recommend at least 4 mm in snowy and icy conditions to ensure sufficient grip. To measure your tyre’s tread depth, simply take a two euro coin:

EURid Reveals the Nominees for The 2017 .eu Web Awards19.10.2017 13:48Pressemelding

EURid, the .eu and .ею registry, has released the nominees for its .eu Web Awards. The .eu Web Awards is an online competition, launched in 2014, where .eu and .ею websites can be nominated for a chance to win a prestigious award to be presented at a stunning ceremony in Brussels. “As with every iteration of the .eu Web Awards, we are so pleased and humbled to award our domain name holders’ online efforts. We are so grateful to have them in our community and want to show them the support they deserve”, commented Giovanni Seppia, EURid’s External Relations Manager. EURid is pleased to unveil this year’s final nominees, which represent the vast diversity and creativity that embodies Europe: The Leaders An established national business that is currently in operation and possesses multiple years of industry experience.

Andersen Tax Launches in Canada19.10.2017 13:30Pressemelding

Andersen Global is proud to announce the launch of the Andersen name in Canada as SdM Chartered Professional Accountants Inc. formally adopts the name Andersen Tax. SdM, a tax firm based in Montreal, Quebec, became a collaborating firm of Andersen Global in June of 2016 and has now formally joined the organization as a member firm under the name Andersen Tax. “We have been working with Simon and the team in Montreal for several years now, and I’m confident that together we will continue finding the best solutions for our clients,” said Global Chairman and CEO of Andersen Tax LLC, Mark Vorsatz. “Our shared name demonstrates the like-mindedness of our partners and the adoption of the Andersen name in Canada further strengthens our growing footprint in the region.” As Andersen Tax, the Canadian team will continue to provide tax, advisory and international tax services with an e

UL Joins Sustainable Apparel Coalition19.10.2017 12:00Pressemelding

UL announces that it has joined the Sustainable Apparel Coalition (SAC) and will use the group’s sustainability measurement tool, the Higg Index, to drive environmental and social responsibility throughout its supply chain. With its membership in the SAC, UL joins more than 200 global brands, retailers and manufacturers, as well as government, non-profit environmental organizations, and academic institutions, which are collectively committed to improving supply chain sustainability in the apparel, footwear and textile industries. UL partners with clients to support them with every aspect of sustainability and supply chain management, including developing a proactive stance and demonstrating ‘green’ and sustainable credentials, assist in gaining better visibility into supply chain issues and mitigate risk and implementing customized and comprehensive Environmental Mana

Phase III Efficacy and Safety Data for Oral Ozanimod in Relapsing Multiple Sclerosis to Be Presented at MSParis2017 – 7th Joint ECTRIMS – ACTRIMS Meeting19.10.2017 11:30Pressemelding

Celgene Corporation (NASDAQ:CELG) today announced that new data on the efficacy and safety of ozanimod, a novel, oral, selective, sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator, in relapsing multiple sclerosis (RMS) were accepted for the MSParis2017 – 7th Joint ECTRIMS – ACTRIMS Meeting, which is being held in Paris, October 25-28, 2017. “Our strong presence at this year’s meeting and the breadth of data being presented on ozanimod highlight our commitment to bringing forth ozanimod as a potential novel, oral therapeutic option for people with multiple sclerosis,” said Terrie Curran, President, Celgene Inflammation and Immunology. Full results from the phase III SUNBEAM™ and RADIANCE™ Part B studies evaluating two doses of oral ozanimod compared with Avonex® (interferon beta-1a) (IFN) in people with RMS will be presented as an oral and a late-break

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom