The FDA expanded the approval of empagliflozin (Jardiance) on Dec. 2 to reduce the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease.
In 2014, the FDA approved empagliflozin as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes. As part of that approval, the FDA required Boehringer Ingelheim Pharmaceuticals, Inc. to conduct a postmarketing study, which enrolled more than 7,000 patients with type 2 diabetes and cardiovascular disease.
During that postmarketing trial, patients who received empagliflozin and standard of care therapies for diabetes and atherosclerotic cardiovascular disease had a 38 percent reduced risk of cardiovascular death compared with a placebo group.
Results of that study, known as the EMPA-REG OUTCOME trial, were published in the New England Journal of Medicine in September 2015. The results were simultaneously presented at the European Association for the Study of Diabetes conference in Sweden.
On June 28, an FDA advisory panel voted 12-11 in favor of empagliflozin’s expanded approval.
Empagliflozin is in a class of medications known as sodium glucose co-transporter 2 inhibitors. The two other FDA-approved SGLT2 inhibitors are dapagliflozin (Farxiga) and canagliflozin (Invokana).
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.