FDA Extends Diabetic Drug Jardiance’s Label to Include Protection from Cardiovascular Death
The FDA extended the label of Jardiance, originally approved in 2014 to treat Type 2 diabetes, to include the claim that it also reduces the risk of death from heart problems.
The agency’s decision is based on an FDA-required postmarketing study that enrolled more than 7,000 patients with Type 2 diabetes and cardiovascular disease. Jardiance (empagliflozin) was shown to reduce the risk of cardiovascular death compared to a placebo when added to standard therapies.
Jardiance was developed by Boehringer Ingelheim and Eli Lilly & Co. In June, an FDA advisory committee narrowly backed the new indication.