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Lokelma approved in Japan
for the treatment of hyperkalaemia
26 March 2020 07:00 GMT
Lokelma approved in Japan for the treatment of
Patients in Japan will benefit from Lokelma's rapid and sustained
AstraZeneca's Lokelma (sodium zirconium cyclosilicate) has been
approved in Japan for the treatment of patients with hyperkalaemia
(elevated levels of potassium in the blood).
The approval by Japan's Ministry of Health, Labour and
Welfare was based on positive results from stand-alone studies
in Japan and global clinical trial programmes. It was also
supported by DIALIZE, a global trial for end-stage renal
disease patients on haemodialysis, which demonstrated the
positive efficacy and safety of Lokelma in the management
Lokelma is the first
innovative non-resin potassium binder to be approved in Japan.
Traditional resin-based binders are often associated with poor
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "More than 300,000 patients in Japan suffer from
hyperkalaemia, typically as result of chronic kidney disease or as
a side effect from medications for heart failure. This approval
ensures that this broad patient population, including those
suffering from hyperkalaemia and patients with hyperkalaemia on
stable haemodialysis, can benefit from Lokelma's rapid, sustained potassium control and
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
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
Lokelma is approved for
the treatment of hyperkalaemia in the US, EU, Canada, Hong Kong,
China, Russia and Japan.
High levels of potassium in the blood (generally classified as
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
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 Japan clinical
data package included 11 trials; four pivotal trials that Japanese
patients participated in and seven supportive overseas trials. The
efficacy and safety of Lokelma in Japanese patients were evaluated
primarily in Japan stand-alone trials and international trials
including Japanese patients.
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
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 Cambridge, UK, AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients
worldwide. Please visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
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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
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
5. National Kidney Foundation. Clinical Update on Hyperkalemia.
2014. Accessed 24 February 2020.
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 Lancet. 2017; 390:1211-59.
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
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