Navigation Links
FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes
Date:12/2/2016

SILVER SPRING, Md., Dec. 2, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease.

"Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus," said Jean-Marc Guettier, M.D., C.M., director of the Division of Metabolism and Endocrinology Products in FDA's Center for Drug Evaluation and Research. "Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes."

According to the Centers for Disease Control and Prevention, death from cardiovascular disease is 70 percent higher in adults with diabetes compared to those without diabetes, and patients with diabetes have a decreased life expectancy driven in large part by premature cardiovascular death.

The FDA's decision is based on a postmarketing study required by the agency when it approved Jardiance in 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Jardiance was studied in a postmarket clinical trial of more than 7,000 patients with type 2 diabetes and cardiovascular disease. In the trial, Jardiance was shown to reduce the risk of cardiovascular death compared to a placebo when added to standard of care therapies for diabetes and atherosclerotic cardiovascular disease.

Jardiance can cause dehydration and low blood pressure (hypotension). Jardiance can also cause increased ketones in the blood (ketoacidosis), serious urinary tract infection, acute kidney injury and impairment in renal function, low blood glucose (hypoglycemia) when used with insulin or insulin secretagogues (e.g. sulfonylurea, a medication used to treat type 2 diabetes by increasing the release of insulin in the pancreas), vaginal yeast infections and yeast infections of the penis (genital mycotic infections), and increased cholesterol.

The most common side effects of Jardiance are urinary tract infections and female genital infections.

Jardiance is not intended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Jardiance is contraindicated in patients with a history of serious hypersensitivity reactions to Jardiance, severe renal impairment, end-stage renal disease, or dialysis.

Jardiance is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut. 

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Theresa Eisenman, 301-796-2969, theresa.eisenman@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Logo - http://photos.prnewswire.com/prnh/20151222/317925LOGO

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/fda-approves-jardiance-to-reduce-cardiovascular-death-in-adults-with-type-2-diabetes-300372256.html


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2016 PR Newswire.
All rights reserved


Related medicine technology :

1. FDA APPROVES APTIMA HPV ASSAY FOR USE ON HOLOGICS PANTHER SYSTEM
2. FDA Approves Epaned, a Liquid Form of Enalapril for Children and Adults
3. FDA approves drug tested by Scottsdale Healthcare and TGen
4. FDA Approves Aptima HPV 16 18/45 Genotype Assay for Use on Hologics Panther System
5. PMDA Approves Jarvik 2000 Heart in Japan
6. Cardinal Health Board of Directors Approves Quarterly Dividend, Authorizes Increase to Share Repurchase Program, Announces Board Leadership Changes
7. FDA Approves Pembrolizumab for Advanced Melanoma
8. FDA approves PleximmuneTM for personalized prediction of transplant rejection in children
9. FDA Approves VisionCares Telescope Implant for Macular Degeneration in Patients 65 Years and Older
10. FDA Approves Investigational Study for New Smaller SynCardia Total Artificial Heart
11. European Regulatory Authority Approves Clinical Investigators Request for Compassionate Use with Omeros Corporations OMS721
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/27/2017)... July 27, 2017  West Pharmaceutical Services, Inc. (NYSE: ... for the second-quarter 2017 and updated financial guidance for ... Second-Quarter 2017 Highlights Reported net sales ... the prior-year quarter. Net sales at constant currency (organic) ... EPS was $0.51, compared to $0.60 in the prior-year ...
(Date:7/26/2017)... 2017  Radium Medical Aesthetics, a leading medical aesthetic clinic in ... by effectively addressing several skin conditions from the inside. ... and more fragile. The skin becomes more transparent due to the ... harmful UV rays from the sun contributes to aging skin, causing ... ...
(Date:7/26/2017)... The Galien Foundation announced today the 2017 11 ... Award Nominees. Counted among the global health innovation industry,s most ... technology product achievement that improves the human condition. ... be U.S. Food and Drug Administration (FDA) approved for market ... impact human health. Sales data are not considered by the ...
Breaking Medicine Technology:
(Date:8/18/2017)... (PRWEB) , ... August 18, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The ... says will lift the veil on false teachings pertaining to the mother of the Savior ... teach, you see a far different picture of the role of this historical woman. ...
(Date:8/18/2017)... ... 2017 , ... “Our Mountains to Climb: A Journey of Love and Faith ... together through the faith they shared to overcome struggles in life. “Our Mountains to ... author, Barbara J. Corcoran, a retired teacher and happily married since 1999; the author’s ...
(Date:8/18/2017)... ... August 18, 2017 , ... “Depressed: Super Heroes of the ... to reflect upon the stories and the relevance these tales may have on the ... Jessica Linhart, a former special education teacher, Jessica spends much of her time enjoying ...
(Date:8/18/2017)... , ... August 18, 2017 , ... “Steve the Snake”: ... “Steve the Snake” is the creation of published author, Harold Flash Haskins Jr., a ... a Department of Defense police officer. , “I write moral-based short stories for children ...
(Date:8/17/2017)... ... August 17, 2017 , ... ... announces that it will feature the National Council for Therapeutic Recreation Certification (NCTRC), ... information. , Established in 1981, NCTRC is a non-profit, international organization dedicated to ...
Breaking Medicine News(10 mins):