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

Click here to­ read full press release/ article | Ref: AstraZeneca | Image: Hindustan Times