AstraZeneca's Chronic Kidney Disease Drug Granted US Priority Review
January 06 2021 - 2:46AM
Dow Jones News
By Jaime Llinares Taboada
AstraZeneca PLC said Wednesday that the U.S. Food and Drug
Administration has granted priority review to its Farxiga medicine
for the treatment of chronic kidney disease.
The British-Swedish pharmaceutical major said that the FDA is
targeting the second quarter of 2021 for its regulatory decision,
or Prescription Drug User Fee Action date.
AstraZeneca said Farxiga was granted priority review based on
clinical evidence from a Phase II trial, and noted that, in March
2020, an independent committee recommended that the trial be
stopped early based on its determination of overwhelming
efficacy.
"Farxiga has the potential to be a truly transformational
medicine across a breadth of diseases, including type-2 diabetes,
heart failure with reduced ejection fraction and, if approved,
chronic kidney disease," BioPharmaceuticals R&D's Executive
Vice President Mene Pangalos said.
Chronic kidney disease is associated with heightened risk of
heart disease or stroke, and is expected to become the world's
fifth leading cause of mortality by 2040, AstraZeneca said.
Write to Jaime Llinares Taboada at jaime.llinares@wsj.com;
@JaimeLlinaresT
(END) Dow Jones Newswires
January 06, 2021 02:31 ET (07:31 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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