The approval by the NMPA was based on data from the Phase IIIb DIALIZE trial, the first ever randomised, placebo-controlled trial to evaluate a potassium binder in patients on stable haemodialysis. The trial showed sustained potassium control pre-dialysis for more patients receiving Lokelma, compared with placebo.1
Lokelma was approved for the treatment of adult patients with hyperkalaemia in
In DIALIZE, 41% of patients receiving Lokelma maintained pre-dialysis potassium levels on at least three out of four dialysis treatments after the long interdialytic interval and did not require urgent rescue therapy. This compared with 1% of patients receiving placebo, making it a statistically significant and clinically meaningful improvement (p5.5 mmol/L.8 Patients with high variability in potassium levels between dialysis sessions are at significant risk of arrhythmias, which can lead to cardiac arrest.4 Worldwide, there are an estimated 700 million and 64 million people living with CKD and HF respectively with hyperkalaemia occurring in 23 to 47% of patients with advanced CKD (stage 3-4) and/or HF.9-11
DIALIZE
DIALIZE is the first ever randomised, placebo-controlled trial to evaluate a potassium binder in patients on stable haemodialysis. The Phase IIIb, multicentre, double-blinded trial investigated the efficacy and safety of Lokelma versus placebo in 196 patients on haemodialysis with hyperkalaemia. Patients were randomised to receive Lokelma or placebo once daily on non-dialysis days for a treatment period of eight weeks. This included a four-week dose adjustment phase (starting at 5g and titrated weekly in 5g increments up to a maximum of 15g) and a four-week evaluation phase on stable dose.
The full results of the DIALIZE trial were published in
Lokelma
Lokelma (sodium zirconium cyclosilicate) is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a highly selective potassium-removing medicine. It is administered orally, is odourless, tasteless and stable at room temperature.12.13 It has been studied in three double-blinded, placebo-controlled trials and in one 12-month open label clinical trial in patients with hyperkalaemia.
Cardiovascular, Renal and Metabolism (CVRM) together forms one of
Contacts
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References
1, Fishbane S et al. A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study of Sodium Zirconium Cyclosilicate for Reducing the Incidence of Predialysis Hyperkalemia. J Am Soc Nephrol 2019.
2. Wang F et al. Executive summary for the 2015 Annual Data Report of the China Kidney Disease Network (CK-NET).
3. Kovesdy CP. Management of hyperkalaemia in chronic kidney disease. Nat Rev Nephrol.
4. Kovesdy CP. et al. Serum and Dialysate Potassium Concentrations and Survival in Hemodialysis Patients. Clin J Am Soc Nephrol. 2007:2:999-1007.
5. Evans KJ, Greenberg A. Hyperkalemia: A review. J Intensive Care Med. 2005;20:272-290.
6. Kramer A et al.
7. United States Renal Data System. 2018 Annual Data Report Volume 2:
8. Xu H et al. Prevalence of hyperkalemia in DOPPS: A real-world, international cohort of hemodialysis patients (MP371). presented at: ERA-EDTA Annual Congress 2017, 2019
9. Vos T et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: A systematic analysis for the Global Burden of Disease Study 2016. The Lancet2017; 390(10100):1211-59.
10. James SL et al. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: A systematic analysis for the Global Burden of Disease Study 2017. The
11. Latts LM et al. Hyperkalemia Is Prevalent in Patients with Cardiorenal Comorbidities. presented at: ISPOR 20th Annual International Meeting, 2015 May 16 - 20,
12. LOKELMA® (sodium zirconium cyclosilicate) US Prescribing Information; last update:
13. Kosiborod M et al. Effect of sodium zirconium cyclosilicate on potassium lowering for 28 days among outpatients with hyperkalemia: The HARMONIZE randomized clinical trial. JAMA 2014; 312(21):2223-33.
Approval ID: Z4-29004 | Date of Preparation:
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