In light of new evidence, the US Food and Drug Administration (FDA) has approved a new indication for Boehringer Ingelheim’s cardiovascular drug, Jardiance. The drug can now be prescribed to reduce the risk of cardiovascular death, due to events like heart attack and stroke, in patients with type 2 diabetes.
“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 anti-diabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes.”
Adult patients with diabetes face a 70 percent increased risk of death from cardiovascular disease, according to statistics from the Centers for Disease Control and Prevention (CDC). Compared to people without diabetes, these patients have a shortened life expectancy.
Jardiance was originally approved by the FDA in 2014 to help patients with type 2 diabetes better manage their blood sugar. The drug’s original indication allowed it to be prescribed alongside changes in diet and exercise.
Based on the results of a postmarketing clinical trial conducted by Boehringer Ingelheim, Jardiance’s list of indications was expanded. The study – which involved 7,000 patients with comorbid type 2 diabetes and cardiovascular disease – found that Jardiance reduced the risk of cardiovascular death, compared to a placebo.
While the new FDA-approved indication is a win for Boehringer Ingelheim, the approval comes with some restrictions. Jardiance must be used in conjunction with medications used to manage diabetes, as well as therapies meant to control atherosclerotic cardiovascular disease.