AstraZeneca's Lokelma Gets FDA Fast-Track Designation in Patients on Chronic Hemodialysis
November 17 2021 - 09:57AM
Dow Jones News
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.
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Feb 2024 to Mar 2024
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Mar 2023 to Mar 2024