FDA Approves Empagliflozin to Reduce Cardiovascular Death in Adults With Type 2 Diabetes
December 2, 2016. The US Food and Drug Administration has approved a new indication for empagliflozin to reduce the risk of cardiovascular (CV) death in adult patients with type 2 diabetes (T2D) and cardiovascular disease. This decision is based on a postmarketing study of more than 7,000 patients with T2D and CV disease. This study found that empagliflozin reduced the risk of CV death vs placebo when added to standard of care therapies for diabetes and atherosclerotic CV disease.