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AstraZeneca Announces Fast Track Designation For FARXIGA - Quick Facts

AstraZeneca (AZN.L,AZN) said the US FDA has granted Fast Track designation for the development of FARXIGA to reduce the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction or preserved ejection fraction. The designation is based on two Phase III trials, DAPA-HF and DELIVER.

FARXIGA is currently approved as a monotherapy and as part of combination therapy to improve glycemic control in adults with type 2 diabetes. In August, FARXIGA was granted Fast Track designation for the development to delay the progression of renal failure and prevent cardiovascular and renal death in patients with chronic kidney disease.

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