FDA Advisory Committee accepts evidence of positive CV effect of Jardiance (empagliflozin) for type 2 diabetes patients.- Eli Lilly + Boehringer

An FDA Advisory Committee voted 12-11 that substantial evidence exists to establish that Jardiance (empagliflozin) reduces cardiovascular (CV) death in adults with type 2 diabetes (T2D) and established CV disease. Jardiance, which is marketed by Boehringer Ingelheim and Eli Lilly and Company, is the only oral T2D medicine shown in a clinical trial to reduce the risk of CV death.

The recommendation was made by the Endocrinologic and Metabolic Drugs Advisory Committee based on data from the landmark EMPA-REG OUTCOME trial, which found that Jardiance significantly reduced the risk of the combined endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14 percent when added to standard of care in adults with T2D and established CV disease. The primary finding was driven by a 38 percent reduction in CV death, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. The overall safety profile of Jardiance was consistent with that of previous trials.

Comment: The question to be asked is this a SGLT-2 class effect ? Johnson & Johnson has a CV risk trial for Invokana to report next year and AstraZeneca will have in 2019 CV results for its Forxiga.