FDA approves Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and CV disease.-Boehringer + Eli Lilly.
The FDA has approved a new indication for Jardiance (empagliflozin) from Boehringer + Eli Lilly, to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease.
The FDA’s decision is based on a postmarketing study (EMPA-REG OUTCOME trial) required by the agency when it approved Jardiance in 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Jardiance was studied in a postmarket clinical trial of 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.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.