By Colin Kellaher

 

AstraZeneca PLC on Wednesday said the U.S. Food and Drug Administration granted fast-track designation to its potassium-removing drug Lokelma to reduce arrhythmia-related cardiovascular outcomes in patients with recurrent hyperkalemia who are on chronic hemodialysis.

The U.K. drug maker said it is currently conducting a Phase III study of Lokelma in that patient population, noting that recurrent hyperkalemia is a prevalent condition in patients with chronic kidney disease and heart failure that remains a burden once they are on chronic hemodialysis.

AstraZeneca said it expects results from the study in 2024.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Lokelma is currently approved around the world for the treatment of hyperkalemia. The FDA and the European Commission last year approved label updates to include a dosing regimen specifically to treat patients with end-stage renal disease who are on chronic hemodialysis.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

November 17, 2021 10:42 ET (15:42 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.
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