Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals’ drug, Jardiance, got approval from the U.S. Food and Drug Administration Friday as a new indication reducing the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease. Shares jump 3% intraday.
The decision is based on a postmarketing study required by the FDA when it approved Jardiance in 2014 as an adjunct to diet and exercise, according to an FDA statement Dec. 2.
Jardiance was studied in a postmarket clinical trial of more than 7,000 patients with type 2 diabetes and cardiovascular disease. In the trial, the drug 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.
“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,” Jean-Marc Guettier, director of the division of metabolism and endocrinology products in FDA’s Center for Drug Evaluation and Research.