Jardiance's Cardiovascular Benefit Claim Bodes Well For Other Products Too

US labeling for Boehringer/Lilly's SGLT-2 inhibitor empagliflozin includes results from MACE primary endpoint and its individual components in the EMPA-REG trial, but indication statement is limited to CV risk reduction benefit.

The new cardiovascular death risk reduction indication on the US label of Boehringer Ingelheim GMBH and Eli Lilly & Co.'s Jardiance (empagliflozin) paves the way for other type 2 diabetes drugs to pick up CV benefit claims, even when outcomes trial results are mixed as to components of a primary endpoint.

On Dec. 2, FDA added a new indication to Jardiance's existing claim for glycemic control: to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established CV disease

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