The European Commission has approved a label update for AstraZeneca’s (NYSE:AZN) type 2 diabetes med Forxiga (dapagliflozin) to include cardiovascular (CV) benefit data generated in the Phase 3 DECLARE-TIMI 58study.
The good news is the study showed that treatment with Forxiga resulted in a statistically significant reduction in the composite of hospitalization for heart failure or CV death compared to placebo. The bad news is the separation from control on the other primary endpoint, the number of major adverse CV events, failed to achieve statistical significance.
Results from the 17,000-subject trial were published in The New England Journal of Medicine in January.
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