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AstraZeneca recently announced that the U.
Hyperkalemia (HK) is a common disease in patients with chronic kidney disease (CKD) and heart failure (HF), affecting 24% to 48% of patients with advanced (3-4) CKD and/or HF.
Fast Track Qualification (FTD) aims to accelerate drug development and rapid review for serious diseases to address serious unmet medical needs in key areas
This FTD is based on Lokelma's potential to reduce severe adverse cardiovascular outcomes in this patient population to address the severe unmet medical needs
Hyperkalemia (usually classified as serum potassium level >5.
The active pharmaceutical ingredient of Lokelma is sodium zirconium cyclosilicate, which is a water-insoluble and non-absorbable potassium ion binder, suitable for the treatment of adult hyperkalemia
Up to now, Lokelma has been approved for the treatment of patients with hyperkalemia (HK) in the United States, the European Union, Canada, China (including mainland China and Hong Kong), Russia, and Japan
In China, Lokelma (Libezol, Sodium Zirconium Cyclosilicate Powder) was approved in January 2020 for the treatment of adult hyperkalemia
Note: The original text has been deleted
Original source: LOKELMA® Granted Fast Track Designation in the US to Reduce Cardiovascular Outcomes in Patients on Chronic Hemodialysis With Hyperkalemia