Jardiance approved by FDA to reduce risk of CV death in adults with type 2 diabetes

Jack Woodfield
Mon, 05 Dec 2016
Jardiance approved by FDA to reduce risk of CV death in adults with type 2 diabetes
The type 2 diabetes drug Jardiance (empagliflozin) has been approved by the US Food and Drug Administration (FDA) to reduce the risk of cardiovascular (CV) death.

Jardiance is an SGLT2 inhibitor which works by helping the kidneys excrete glucose from the bloodstream through urine.

The drug is prescribed to people with type 2 diabetes in the UK either as monotherapy when metformin is not suitable or alongside other glucose-lowering medications such as insulin when blood glucose levels are poorly controlled. It is not indicated for type 1 diabetes.

The FDA first approved Jardiance to improve blood glucose levels among people with type 2 diabetes in 2014, but the agency required further evidence before approving it as a CV treatment.

This new approval is based on a postmarketing trial of 7,000 patients, all of whom had type 2 diabetes and CV disease, where Jardiance was shown to reduce the risk of CV death compared to a placebo when added as an adjunct to diet and exercise.

The Centers for Disease Control and Prevention estimates that death from CV disease is roughly 70 per cent higher in adults with diabetes. This is a significant factor in why people with diabetes have a decreased life expectancy.

"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 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."

Jardiance was approved by the European Commission (EC) in May 2014.
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