AstraZeneca Reports Label Update with Positive Cardiovascular Outcomes and Renal Data for Forxiga (dapagliflozin) in EU
Shots:
- The EC has approved label update which is based on Phase III DECLARE-TIMI 58 study results assessing Forxiga vs PBO on CV outcomes in 17-000 patients with T2D at risk of CV events across 33 countries
- The P-III DECLARE-TIMI 58 study results: reduction in hospitalization for heart failure/CV deaths- safe and effective with no imbalance in amputations- fractures- bladder cancer or Fournier’s gangrene. The inclusion of these results is under regulatory review in the US & China
- Forxiga (PO- qd) is an SGLT2 inhibitor indicated as monothx. as well as combination therapy to improve glycaemic control with weight loss and blood-pressure reduction as an adjunct to diet and exercise in patients with T2D
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