LOKELMA® Granted FDA Fast Track Designation to Reduce Cardiovascular Outcomes in Chronic Hemodialysis Patients with Recurrent Hyperkalemia

News on November 17, 2021 /BIOON/ -- AstraZeneca recently announced that the U.S. Food and Drug Administration (FDA) has grantedNew Oral Potassium-Lowering Drug Lokelma (Lizhuo®, Generic Name: Sodium Zirconium Cyclosilicate, ZS-9 Powder)Fast Track Designation (FTD):For patients with recurrent hyperkalemia (HK) undergoing chronic dialysis, to reduce arrhythmia-related cardiovascular outcomes.

Hyperkalemia (HK) is a common condition in patients with chronic kidney disease (CKD) and heart failure (HF)., affecting 24% to 48% of patients with advanced (stage 3-4) CKD and/or HF. HK remains a burden even after patients undergo chronic hemodialysis.In patients with end-stage renal disease (ESRD) undergoing chronic hemodialysis, HK is associated with increased all-cause and cardiovascular (CV) mortality as well as hospitalization risk.

Fast Track Designation (FTD) aims to accelerate the development and expedite the review of drugs for serious conditions, addressing critical areas of significant unmet medical need. If a drug in development receives Fast Track Designation, it means the pharmaceutical company can engage more frequently with the FDA during the R&D phase. Upon submission of the marketing application, if the relevant criteria are met, the drug is eligible for accelerated approval and priority review, and may also qualify for rolling review.

This FTD is based on the potential of Lokelma to reduce severe adverse cardiovascular outcomes in this patient population, addressing a significant unmet medical need. AstraZeneca is currently investigating Lokelma in the Phase 3 DIALIZE-Outcomes trial. The DIALIZE-Outcomes trial is part of the CRYSTALIZE evidence program, which comprises over 50 clinical and real-world evidence studies examining the potential benefits of Lokelma in managing recurrent hyperkalemia (HK) across the cardiorenal spectrum. The DIALIZE-Outcomes trial is currently ongoing, with results expected in 2024.

Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, said: "The DIALIZE-Outcomes trial is the first-ever cardiovascular outcomes trial using a potassium binder in hemodialysis and has the potential to change the standard of care for these patients. The FDA's decision underscores the importance of this trial, which will provide critical information on Lokelma's ability to reduce cardiovascular complications associated with hyperkalemia in patients on chronic hemodialysis."

Hyperkalemia (commonly classified as serum potassium levels >5.0 mmol/L) is a serious condition characterized by elevated potassium levels in the blood. It frequently occurs in patients with chronic kidney disease (CKD) and/or heart failure (HF), particularly in those undergoing hemodialysis or using common cardiac medications (such as renin-angiotensin-aldosterone system inhibitors). Globally, there are up to 700 million CKD patients and up to 64 million HF patients. Hyperkalemia affects 24% to 48% of patients with moderate to advanced (stage 3-4) CKD and/or HF.

The active pharmaceutical ingredient in Lokelma is sodium zirconium cyclosilicate, an insoluble, non-absorbable potassium binder used for the treatment of hyperkalemia in adults.The innovative ion trapping technology adopted by sodium zirconium cyclosilicate has high selectivity for potassium ions, resulting in a faster onset of action and better tolerability. Regardless of the underlying cause of hyperkalemia, and irrespective of age, gender, race, comorbidities, or concomitant use of RAASi, sodium zirconium cyclosilicate can reduce and maintain patients' serum potassium levels within the normal range.

To date, Lokelma has been approved in the United States, the European Union, Canada, China (including mainland and Hong Kong), Russia, and Japan for the treatment of patients with hyperkalemia (HK). In 2020, the U.S. and EU labels for Lokelma were updated to include a dosing regimen specifically for the treatment of hyperkalemia in end-stage renal disease (ESRD) patients undergoing chronic dialysis.

In China, Lokelma (Lizhuo, Sodium Zirconium Cyclosilicate Powder) was approved in January 2020 for the treatment of adult hyperkalemia.After nearly 60 years of vacancy in the field of drug treatment for hyperkalemia, the approval of Lokelma (Lizhuo, Sodium Zirconium Cyclosilicate Powder), the first innovative drug to be launched in China, marks a new era in the treatment of hyperkalemia in China. (Bioon.com)

Source of Original Text:LOKELMA® Granted Fast Track Designation in the US to Reduce Cardiovascular Outcomes in Patients on Chronic Hemodialysis With Hyperkalemia