By Patrick Thomas

AstraZeneca PLC (AZN) said Tuesday that the U.S. Food and Drug Administration granted "fast track" status for the development of its Farxiga drug in patients with chronic kidney disease.

Fast-track programs clear drugs for patients that the FDA considers to be in high need. The drugmaker said Faraxiga, a medication used to treat type 2 diabetes, is being developed to delay the progression of renal failure and prevent cardiovascular and renal death in patients with chronic kidney disease.

"This Fast Track designation is an important step towards more quickly addressing unmet treatment needs in chronic kidney disease, and we will work closely with the FDA to explore the potential for Farxiga to improve outcomes for these patients," Mene Pangalos, AstraZeneca executive vice president said in a press release.

The company said the Phase 3 clinical trial is under way to evaluate the effect of Farxiga on renal outcomes and cardiovascular mortality in patients with chronic kidney disease and without type 2 diabetes versus placebo, on top of standard of care.

Write to Patrick Thomas at patrick.thomas@wsj.com

(END) Dow Jones Newswires

August 27, 2019 08:01 ET (12:01 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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