AstraZeneca's Forxiga (dapagliflozin) Receive NMPA's Approval for Label Update to Include Data of P-III DECLARE-TIMI 58 Study
Shots:
- The updated label includes P-III DECLARE-TIMI 58 study that assesses the effect of Forxiga vs PBO on CV outcomes in 17000+ patients with T2D at risk of CV events also assessed key renal 2EPs- across 882 sites in 33 countries
- The study demonstrated that Forxiga achieved a significant reduction in the composite EP of hHF or CV death. The trial confirmed the well-established safety profile of Forxiga
- The NMPA’s label update follows the update to the EU MAA in Aug’2019 and the US FDA’s approval granted in Oct’2019
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