CHMP adopts a positive opinion acknowledging that Jardiance® reduces the risk of CV death
16.12.2016 14:41 | Business Wire
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).
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’:
Dr Petra Kienle
Product Communication Manager
Phone: +49 (6132) 77 143877
Phone: +1 (317) 478 5423
Om Business Wire
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
European Commission Grants New Indication for Soliris® (Eculizumab) for the Treatment of Patients with Refractory Generalized Myasthenia Gravis (gMG)21.8.2017 13:25 | Pressemelding
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that the European Commission (EC) approved the extension of the indication for Soliris® (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. Soliris is the first and only complement-based therapy approved in the European Union (EU) for this ultra-rare subset of patients.1-4 Patients with refractory gMG can have difficulties walking, talking, swallowing and breathing normally despite therapies currently used for MG. Exacerbations and crises of their disease may require hospitalization and intensive care and may be life-threatening.5-7 Soliris will be launched for this new indication initially in Germany, and Alexion is evaluating launches in additional EU countries. “Patients with refractory gMG have exhausted multiple the
IntegenX Applauds the Passage of the Rapid DNA Act of 201721.8.2017 12:00 | Pressemelding
IntegenX Inc., the global market leader for Rapid DNA human identification, applauds the signing into law of S.139 and HR.510, The Rapid DNA Act of 2017. The legislation will allow law enforcement agencies, under standards and guidelines established by the FBI, to perform real-time DNA testing at time of arrest, within booking stations. Similar to how fingerprint analysis has evolved from a paper and ink practice to a point-of-action technology, DNA testing has now become possible in 90 minutes within a booking station, while a suspect is still in custody. With processing times reduced from weeks to less than two hours, the potential to identify or exonerate a suspect quickly will make a meaningful impact on law enforcement. IntegenX thanks U.S. Senate sponsor Senator Orrin Hatch (R-UT) and lead co-sponsor Senator Dianne Feinstein (D-CA) as well as House sponsor Congressman
PPG Completes COLORFUL COMMUNITIES Project at Primary School in Kecskemét, Hungary21.8.2017 08:03 | Pressemelding
PPG (NYSE:PPG) today announced the completion of a COLORFUL COMMUNITIES™ project in Kecskemét, Hungary, that helped revitalize the learning environment of the Corvin Mátyás primary school. The Colorful Communities program provides PPG volunteers and products along with financial contributions to bring color and vitality to communities where the company operates around the world, such as in Kecskemét, where the PPG automotive service team operates with 33 employees. The project brought together more than 140 PPG and community volunteers who spent three days at the school revitalizing four classrooms, four changing rooms and the playground. PPG provided more than $20,000 to assist with the project, including more than 460 liters of Héra ® Prémium waterborne interior paint and Trinát ® Aqua wate
Glennmont Partners Completes Refinancing of Sleaford Biomass Plant for £150m21.8.2017 08:00 | Pressemelding
Glennmont Partners has successfully completed the refinancing of the Sleaford Renewable Energy Plant on behalf of its dedicated clean energy fund, Glennmont Clean Energy Fund Europe I, as part of a programme of realisations of value from the Fund. Glennmont Partners is one of Europe’s largest fund managers focusing exclusively on investment in clean energy infrastructure. Glennmont raises long-term capital to invest in alternative power generation projects including wind farms, biomass power stations, solar parks and small-scale hydro power plants. The carefully selected, risk managed investments deliver sustained performance and predictable returns over periods of 10 years or more. Sleaford REP is a 40MWe straw-fired biomass plant located in Lincolnshire, UK. The plant has been in operation since 2014 and is being operated by Burmeister & Wain Scandinavian Contractor (BWSC). The
Boehringer Ingelheim: Advancing anticoagulation care with new data at ESC Congress 201721.8.2017 07:08 | Pressemelding
Boehringer Ingelheim today announced that it will present important new data on the treatment of patients with atrial fibrillation (AF) at the ESC Congress in Barcelona, Spain, 26-30 August 2017. In total, four abstracts have been accepted, investigating different aspects of AF patient treatment. The results of the RE-DUAL PCI™ trial have been selected for one of the Late Breaking Science sessions of the congress. The RE-DUAL PCI™ trial compared dual therapy with triple therapy after percutaneous coronary intervention (PCI) with stent placement in approximately 2,500 adults with atrial fibrillation. Patients were either treated with dabigatran etexilate (Pradaxa®) and a single antiplatelet agent or with the vitamin K antagonist (VKA) warfarin and two antiplatelets. The dabigatran doses investigated in this trial are the same doses which have already demonstrated effective stroke preven
Study Investigates Performance of Masimo PVi® As Part of Goal-Directed Fluid Therapy During Laparoscopic Bariatric Surgery21.8.2017 06:00 | Pressemelding
Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Firat University in Turkey evaluated the performance of Masimo PVi®, a noninvasive and continuous measurement of the dynamic changes in perfusion index (Pi) that occur during respiratory cycles, as the basis of a goal-directed fluid therapy (GDFT) protocol during laparoscopic bariatric surgery on mechanically-ventilated patients.1 In the study, Dr. Demirel and colleagues sought to evaluate whether using GDFT guided by PVi on morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass (RYGB) surgery might result in less intravenous fluid use without compromising outcomes. They enrolled 60 patients and divided them randomly into control and GDFT groups. The control group’s fluid levels were managed by standard fluid therapy, using mean arterial pressure (MAP) and
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom