AstraZeneca’s Forxiga (dapagliflozin) Receive NMPA’s Approval for Label Update to Include Data of P-III DECLARE-TIMI 58 Study

October 28, 2020 Auto Bot approval, AstraZeneca, dapagliflozin, Forxiga, NMPA, P-III, receives, regulatory, results, Trial, Update 0

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

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Pharmaceutical Technology

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