FDA Advisory panel to consider expanding the label of Jardiance (empagliflozin)to include reduction of CV risk in type 2 diabetes patients- Eli Lily + Boehringer

An advisory panel to the FDA will be asked to vote next week on whether Jardiance (empagliflozin) from Eli Lilly & Co and Boehringer Ingelheim reduces the risk of cardiovascular death, according to documents posted on the agency's website.

The documents were published ahead of a June 28 meeting of advisors who will discuss Jardiance, and recommend whether the label should include a claim that it cuts the risk of heart problems in patients at high risk. In January 2016, Eli Lilly and Boehringer submitted the results of the EMPA-REG OUTCOME trial, which showed that Jardiance cut the risk of death from heart attacks and strokes, becoming the first glucose-lowering drug to show protective results in a large clinical trial. The companies now want to add those results to the drug label and claim it improves cardiovascular outcomes in patients at high risk of a heart attack or stroke.

Comment:Jardiance cut the combined risk of cardiac death, non-fatal heart attacks and non-fatal strokes by 14% according to the EMPA-REG OUTCOME trial . It cut the risk of death from any cause by 33%. However, there was no significant difference in the risk of non-fatal heart attack or non-fatal stroke.