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:1/14/2019)... , ... January 14, 2019 , ... The Villas at ... an anniversary party from 2 p.m. to 4 p.m. on Jan. 16. , “Since ... said Rod Burkett, CEO of Gardant Management Solutions, the company that manages the community. ...
(Date:1/14/2019)... , ... January 14, 2019 , ... Dexter foot and ankle podiatry has been serving ... for all your foot and ankle needs! We can help take care of you whether ... top of the foot pain or even any heel or ankle problems. We can ...
(Date:1/11/2019)... Ariz. (PRWEB) , ... January 11, 2019 , ... ... loss products and solutions, is now helping customers transform their gut health. The ... features probiotics and digestive enzymes that complement each other to support better daily ...
Breaking Medicine Technology:
(Date:1/14/2019)... ... ... Early bird pricing for Medical Device Risk Management: Prepare for the Winds ... conflicted, confusing. And it is getting even more complicated , The international standard is ... new standard adds new definitions, changes the clause numbering, introduces new requirements, changes many ...
(Date:1/14/2019)... ... January 14, 2019 , ... ... and availability of VARIZIG® (Varicella Zoster Immune Globulin [Human]) for post-exposure prophylaxis ... In the update, the CDC notes that VARIZIG is commercially available from a ...
(Date:1/14/2019)... ... ... Living Well Providers of 2019. , Acupuncture, Dr. Wai Chu - Homdel ... Dr. Joanna Jodar - Somerset , Dr. Barbara Knoll - Lavallette , ... Dr. Robert J. Reinhardt - Pequannock , Dr. Sylvester Rich - Bound Brook , ...
(Date:1/14/2019)... , ... January 14, 2019 , ... ... availability of the newly updated International Audit Protocol Consortium (IAPC) EHS audit protocol ... audit protocols to understand the scope of their EHS regulatory obligations and rapidly ...
(Date:1/13/2019)... (PRWEB) , ... January 12, 2019 , ... ... Professionals Committee (YPC) in conjunction with Temple University hosted a continuing education (CEU) ... and Mentees. The event aimed to create a series of talks to ...
Breaking Medicine News(10 mins):