AstraZeneca Granted Fast Track Designation for Farxiga
July 16 2020 - 9:12AM
Dow Jones News
By Chris Wack
AstraZeneca said Thursday it has been granted fast track
designation in the U.S. for the development of Farxiga
dapagliflozin to reduce the risk of hospitalization for heart
failure or cardiovascular death in adults following an acute
myocardial infarction or heart attack.
The company said the designation is based on a Phase III DAPA-MI
trial that will explore the efficacy and safety of Farxiga in this
patient population.
The DAPA-MI trial is conducted in collaboration with Uppsala
Clinical Research Center and Minap in the U.K. It will explore the
benefit of Farxiga in patients without type-2 diabetes following an
acute MI. It is expected to begin recruiting in the fourth quarter
of 2020.
In May, Farxiga was approved in the U.S. to reduce the risk of
CV death and hHF in adults with HF with reduced ejection fraction
with and without T2D. Farxiga is also indicated as an adjunct to
diet and exercise to improve glycemic control in adults with T2D.
Additionally, Farxiga is being evaluated for patients with chronic
kidney disease in the Phase III DAPA-CKD trial, which was stopped
early after a Data Monitoring Committee determination of
overwhelming efficacy.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 16, 2020 08:57 ET (12:57 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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