The US Food and Drug Administration (FDA) announced Friday that it would allow a new indication for Eli Lilly’s Jardiance (empagliflozin) to lower the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease.
Empagliflozin was previously approved by the FDA in 2014 to aid in reducing blood sugar in patients with type 2 diabetes. At the time, the FDA requested that a separate trial be done to demonstrate the drug did not raise the risk of cardiovascular problems.
Jean-Marc Guettier, M.D., C.M., director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research, 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.”
Not only did the study show no risk of cardiovascular problems, but results indicated empagliflozin cut deaths by 32 percent in patients with type 2 diabetes at risk of heart attack and stroke, when added to standard diabetes medications.
Empagliflozin was looked at in a post-approval clinical trial involving more than 7,000 patients with type 2 diabetes and cardiovascular disease. In the trial, Jardiance was shown to reduce the risk of cardiovascular death compared to a placebo when added to standard of care therapies for diabetes and atherosclerotic cardiovascular disease.
Empagliflozin is one of a new class of treatments known as SGLT2 inhibitors, which includes Johnson & Johnson’s Invokana and AstraZeneca Plc’s Farxiga. They are available as single-ingredient products and also in combination with other diabetes medicines such as metformin. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine.
SGLT2 inhibitors are not intended or approved for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.