AstraZeneca PLC - Lokelma approved in Japan for hyperkalaemia
Lokelma approved in
AstraZeneca's Lokelma (sodium zirconium cyclosilicate) has been approved in
The approval by
Lokelma is the first innovative non-resin potassium binder to be approved in
The global clinical trial programme showed that for patients receiving Lokelma, for up to 12-months in duration, the median time to achieving normal potassium levels in the blood was 2.2 hours, with 98% achieving normal levels within 48 hours from baseline.1 Lokelma demonstrated a rapid reduction of potassium in the blood as early as one hour with one dose and a sustained treatment effect for up to one year.2,3 In the DIALIZE trial, Lokelma demonstrated significantly improved control of pre-dialysis hyperkalaemia compared with placebo.4 Lokelma was well tolerated, with few serious adverse events.3,4 Results in Japanese patients were broadly consistent with those seen in the global programme.
Lokelma is approved for the treatment of hyperkalaemia in the US, EU,
High levels of potassium in the blood (generally classified as >5mmol/l)5 characterise hyperkalaemia. The risk of hyperkalaemia increases significantly for patients with chronic kidney disease (CKD) and for those who take common medications for heart failure (HF), such as renin-angiotensin-aldosterone system inhibitors, which can increase potassium in the blood. Hyperkalaemia occurs in 23% to 47% of patients with CKD and/or HF with an estimated 700 million and 64 million people, respectively, living with each condition worldwide.6,7
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. The Lokelma global clinical trials programme consists of multiple trials of up to 12-months duration. The
AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM) together forms one of AstraZeneca's three therapy areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. The Company's ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal and Metabolism, and Respiratory. Based in
1. 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):2223-2233.
2. Ash S et al. A Phase 2 Study on the Treatment of Hyperkalemia in Patients with Chronic Kidney Disease Suggests that the Selective Potassium Trap, ZS-9, is Safe and Efficient. Kidney Int. 2015; 88, 404-411.
3. Roger SD et al. Efficacy and Safety of Sodium Zirconium Cyclosilicate for Treatment of Hyperkalemia: An 11-Month Open-Label Extension of HARMONIZE. Am J Nephrol. 2019;50(6):473-480.
4. Fishbane S et al. Long-term Efficacy and Safety of Sodium Zirconium Cyclosilicate for Hyperkalemia: A 12-Month, Open-Label, Phase 3 Study. Clin J Am Soc Nephrol. 2019;30.9, 1723-1733.
6. 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
7. 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
This information is provided by RNS, the news service of the
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