Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

FDA Approves Jardiance for Patients with Type 2 Diabetes and Cardiovascular Disease

XTALKS VITALS NEWS

FDA

The drug can now be prescribed to reduce the risk of cardiovascular death, due to events like heart attack and stroke, in patients with type 2 diabetes.

Share this!

December 6, 2016 | by Sarah Hand, M.Sc.

In light of new evidence, the US Food and Drug Administration (FDA) has approved a new indication for Boehringer Ingelheim’s cardiovascular drug, Jardiance. The drug can now be prescribed to reduce the risk of cardiovascular death, due to events like heart attack and stroke, in patients with type 2 diabetes.

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

Adult patients with diabetes face a 70 percent increased risk of death from cardiovascular disease, according to statistics from the Centers for Disease Control and Prevention (CDC). Compared to people without diabetes, these patients have a shortened life expectancy.



Jardiance was originally approved by the FDA in 2014 to help patients with type 2 diabetes better manage their blood sugar. The drug’s original indication allowed it to be prescribed alongside changes in diet and exercise.

Based on the results of a postmarketing clinical trial conducted by Boehringer Ingelheim, Jardiance’s list of indications was expanded. The study – which involved 7,000 patients with comorbid type 2 diabetes and cardiovascular disease – found that Jardiance reduced the risk of cardiovascular death, compared to a placebo.

While the new FDA-approved indication is a win for Boehringer Ingelheim, the approval comes with some restrictions. Jardiance must be used in conjunction with medications used to manage diabetes, as well as therapies meant to control atherosclerotic cardiovascular disease.


Keywords: FDA, Type 2 Diabetes, Cardiovascular Disease


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Better Meal Planning for Diabetics Using a Predictive Blood Sugar App

April 21, 2017 - A new app could allow people with type 2 diabetes to make predictions about the impact of a meal on their blood sugar levels, before they even take a bite.

Featured In: Life Science News


Bacterial Biomarkers Could Make Diagnosing Colorectal Cancer Less Invasive

April 20, 2017 - Researchers at The University of Texas Health Science Center at Houston School of Public Health have identified specific strains of gut bacteria which have been associated with colorectal cancer.

Featured In: Life Science News


Weetabix Cereal Sold to Post in £1.4 Billion Deal

April 20, 2017 - The cereal was sold by Shanghai-based Bright Food, which acquired a controlling stake in the company in 2012.

Featured In: Food News

LEAVE A COMMENT
 
  
THE XTALKS VITALS LIFE SCIENCE BLOG

What Medical Device Manufacturers Need to Know Before Developing a Biological Safety Evaluation

REGISTER FOR THESE WEBINARS

Electronic Informed Consent: 2017 Industry Survey Results


Critical CRO Oversight Metrics: How to Establish the Right Metrics and Monitor them in Real-Time


The Modernization of eCOA Technology for Clinical Trials


Developing a Biological Safety Evaluation


Copyright © 2016-2017 Honeycomb Worldwide Inc.