The agency’s decision was based on the results of a postmarketing study it required when it initially approved Jardiance in August 2014 as an adjunct to diet and exercise to enhance glycemic control in adults with T2D mellitus.
In a clinical trial of over 7000 patients with T2D and CVD, the use of Jardiance was demonstrated to reduce the risk of cardiovascular death compared with placebo when added to standard of care therapies for diabetes and atherosclerotic CVD.
Diabetic patients are 70% more likely to die from CVD than those without diabetes, according to the Centers for Disease Control and Prevention.
The most common adverse events experienced by trial participants treated with Jardiance included urinary tract infections and female genital infections.
The drug’s use has also been tied to dehydration, hypotension, ketoacidosis, acute kidney injury, renal function impairment, hypoglycemia when used with insulin or insulin secretagogues, genital mycotic infections, and increased cholesterol.
FDA center for drug evaluation and research director of the division of metabolism and endocrinology products Jean-Marc Guettier said: “Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus.
“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.”
Image: FDA Building 51 houses the Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration.