AstraZeneca: FDA Grants Fast Track Designation for Farxiga in Heart Failure

Date : 09/16/2019 @ 12:24PM
Source : Dow Jones News
Stock : Astrazeneca Plc (AZN)
Quote : 7402.0  185.0 (2.56%) @ 1:37PM
Astrazeneca share price Chart

AstraZeneca: FDA Grants Fast Track Designation for Farxiga in Heart Failure

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By Michael Dabaie

 

AstraZeneca PLC (AZN) said the U.S. Food and Drug Administration granted fast track designation for Farxiga in heart failure.

The company said it was granted the 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 FDA's fast track program is designed to accelerate the development and review of new medicines for the treatment of serious conditions where there is an unmet treatment need.

The drug is currently approved as a monotherapy and as part of combination therapy to improve glycemic control in adults with type 2 diabetes. In August, the FDA granted fast track approval for the development of Farxiga to delay the progression of renal failure and prevent cardiovascular and renal death in patients with chronic kidney disease.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

September 16, 2019 08:09 ET (12:09 GMT)

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