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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