FDA fast tracks blockbuster diabetes drug for heart failure

News
Article

FDA granted Fast Track designation to a popular diabetes drug to reduce the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.

Mohamed Eid

Eid

FDA granted Fast Track designation to empagliflozin (Jardiance, Boehringer Ingelheim and Eli Lilly and Company) to reduce the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.

The once-daily tablet Jardiance is a popular medication that treats type 2 diabetes.

Related: FDA Warns Maker Of Ingredient In Huge Heart Drug Recall

“Heart failure contributes to 1 in 9 deaths and is a leading cause of hospitalization in the U.S., yet there are limited treatment options for people living with this debilitating disease,” said Mohamed Eid, MD, MPH, vice president of clinical development & medical affairs for Boehringer Ingelheim, in a statement from the company. “The FDA Fast Track designation for empagliflozin is an important step forward in addressing this unmet need, and we look forward to working closely with the FDA as we explore the potential for empagliflozin to improve outcomes for adults with chronic heart failure."

Already affecting 26 million people worldwide, including more than 6.5 million in the U.S., heart failure is expected to become even more prevalent, Boehringer Ingelheim said.

Related: Top 4 Drugs In The Pipeline

This designation is for the ongoing EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved studies. The studies will evaluate the effect of empagliflozin on cardiovascular death and hospitalization for heart failure in adults with chronic heart failure with reduced or preserved ejection fraction.

The two EMPEROR phase 3 studies include more than 8,500 people with chronic heart failure.

Read more: Cybersecurity Glitch Wreaks Havoc On Insulin Pumps

Recent Videos
Sean M. Oser, MD, MPH, an expert on diabetes
Sean M. Oser, MD, MPH, an expert on diabetes
Sean M. Oser, MD, MPH, an expert on diabetes
Sean M. Oser, MD, MPH, an expert on diabetes
Sean M. Oser, MD, MPH, an expert on diabetes
Video 5 - "Obstacles in Adapting Diabetes Technology to Individual Needs" - 1 KOL is featured
Video 4 - "The Impact of Continuous Glucose Monitors & Digital Solutions on Diabetes Care"
Video 3 - "The Pivotal Role of Patient Engagement and Education in Achieving Optimal Diabetes Outcomes"
Video 2 - "Addressing Coexisting Conditions: Keys to Comprehensive Diabetes Care"
Video 1 - "The Influence of Social Determinants of Health on Diabetes Care and Outcomes"
Related Content
© 2024 MJH Life Sciences

All rights reserved.