AstraZeneca's (AZN) LOKELMA Granted Fast Track Designation in the US to Reduce Cardiovascular Outcomes in Patients on Chronic Hemodialysis With Hyperkalemia

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Go back to AstraZeneca's (AZN) LOKELMA Granted Fast Track Designation in the US to Reduce Cardiovascular Outcomes in Patients on Chronic Hemodialysis With Hyperkalemia

LOKELMA® Granted Fast Track Designation in the US to Reduce Cardiovascular Outcomes in Patients on Chronic Hemodialysis With Hyperkalemia

November 17, 2021 10:03 AM EST

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca has been granted Fast Track Designation in the United States (US) for the development of LOKELMA® (sodium zirconium cyclosilicate) to reduce arrhythmia-related cardiovascular outcomes in patients on chronic hemodialysis with recurrent hyperkalemia (HK). The designation is based on the potential of LOKELMA to reduce serious adverse CV outcomes in this patient population, addressing a significant unmet medical need. This is being investigated in the ongoing Phase III DIALIZE-Outcomes trial.

HK is a prevalent condition in patients with chronic kidney disease (CKD) and heart failure (HF), affecting 24% to 48% of patients with... More