AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Priority Review Voucher for the Reduction of CV Risks and Death in Patients with Type-2 Diabetes

AstraZeneca’s Qternmet XR (dapagliflozin, saxagliptin, metformin hydrochloride) Receives FDA’s Approval for Type-2 Diabetes in the US

Shots:

  • The Farxiga’s sNDA is based on P-III DAPA-HF trial involves assessing of Farxiga + SoC (10mg, qd) vs PBO in patients with heart failure and reduced ejection fraction (LVEF ≤ 40%), with/out T2D
  • The study resulted in a reduction in the incidence of the composite outcome of CV death or the worsening of HF and is also published in NEJM 2019. Additionally, in Sep 2019 & Aug 2019, the US FDA granted Fast Track designation to Farxiga for HF and to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease, with/out T2D
  • Farxiga (dapagliflozin, qd) is an oral SGLT2 inhibitor targeted as monothx and in combination with multiple therapies to improve glycaemic control, with the additional benefits of weight loss and BP reduction, as an adjunct to diet and exercise in adults with T2D evaluated in P-IIb/III trials in 35,000 patients

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