11 August 2016 - Approval based on cardiovascular outcome clinical trial EMPA-REG OUTCOME, which demonstrated empagliflozin significantly reduced the incidence of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease.

Boehringer Ingelheim and Eli Lilly announced today that Health Canada has approved a new indication for Jardiance (empagliflozin), as an adjunct to diet, exercise and standard care therapy, to reduce the incidence of cardiovascular (CV) death in patients with type 2 diabetes and established CV disease who have inadequate glycemic control.

Jardiance received an initial Notice of Compliance from Health Canada on 23 July 2015, to be used as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. On 27 July 2016, based on data from the EMPA-REG OUTCOME trial, Health Canada approved the new indication to include adult patients with type 2 diabetes and established CV disease.

Read Boehringer Ingelheim press release