FDA grants AstraZeneca fast track designation for the development of Lokelma
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AstraZeneca has been granted fast track designation in the U.S. for the development of Lokelma, according to a company press release.
Lokelma (sodium zirconium cyclosilicate) is a “highly selective, oral potassium-removing agent” designed to lessen arrhythmia-related cardiovascular outcomes in patients on chronic hemodialysis with recurrent hyperkalemia.
Currently, researchers are investigating the potential of Lokelma in reducing serious adverse cardiovascular events in this population in the phase 3 DIALIZE-Outcomes trial.
“The DIALIZE-Outcomes trial is the first-ever cardiovascular outcomes trial with a potassium binder in hemodialysis and has the potential to transform standard of care for these patients,” Mene Pangalos, executive vice president of biopharmaceuticals research and development for AstraZeneca, said in the release. “The FDA decision demonstrates the importance of this trial, which will offer important information on Lokelma’s ability to reduce potentially deadly cardiovascular complications associated with hyperkalemia for patients on chronic hemodialysis.”
Results from the DIALIZE-Outcomes trial are expected to be released in 2024.
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