CHMP adopts a positive opinion acknowledging that Jardiance reduces the risk of CV death

CHMP adopts a positive opinion acknowledging that Jardiance reduces the risk of CV death

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In the EMPA-REG OUTCOME A trial Jardiance A reduced the risk of cardiovascular death by 38 percent vs placebo in patients with type 2 diabetes and established CV disease when added to standard of care The Committee for Medicinal Products for Human Use recommends to update the existing label of Jardiance A for the treatment of adults with insufficiently controlled T2D This is the first time the CHMP supports the use of a diabetes treatment for its effect on both glycaemic control and CV events )–The Committee for Medicinal Products for Human Use of the European Medicines Agency today adopted a positive opinion to update the JardianceA label including a change to the indication statement.