CHMP Issues Positive Opinion to Expand Labeling of Jardiance, Synjardy and Glyxambi to Include Positive Effects on Cardiovascular and Renal Outcomes



Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to update the labels of Jardiance (empagliflozin), Synjardy (empagliflozin and metformin) and Glyxambi (empagliflozin and linagliptin) to include additional important data from the landmark EMPA-REG OUTCOME trial on heart failure and kidney endpoints.

The labels now include additional results from the EMPA-REG OUTCOME trial, specifically a relative risk reduction in hospitalisation for heart failure by 35 percent and a relative risk reduction for new-onset or worsening of kidney disease by 39 percent with empagliflozin, compared with placebo, in people with type 2 diabetes and established cardiovascular disease

“Heart failure and kidney disease are highly prevalent in people with type 2 diabetes and are associated with high morbidity and mortality,” commented Dr Waheed Jamal, Corporate Vice President, Head of CardioMetabolic Medicine, Boehringer Ingelheim. “Due to the current unmet medical need to treat these conditions, we are pleased that the European Medicines Agency has recognised the demonstrated benefits of empagliflozin to reduce the risks of heart failure and kidney disease in people with type 2 diabetes and established cardiovascular disease.”

“In the EMPA-REG OUTCOME® trial, empagliflozin demonstrated superiority in reducing the risk of cardiovascular death in people with type 2 diabetes and established cardiovascular disease,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly Diabetes. “As a result, empagliflozin was the first type 2 diabetes treatment to have either a cardiovascular indication or data on the reduction of the risk of cardiovascular death included in the label.”