# AstraZeneca Lokelma approved in Japan for the treatment of patients with hyperkalaemia

- Link: https://www.directorstalkinterviews.com/astrazeneca-lokelma-approved-in-japan-for-the-treatment-of-patients-with-hyperkalaemia/412809955
- Published: 2020-03-26T07:39:15+00:00
- Author: Amilia Stone

**[AstraZeneca PLC](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
_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 of hyperkalaemia.

_Lokelma_ is the first innovative non-resin potassium binder to be approved in Japan.
Traditional resin-based binders are often associated with poor tolerability.

> **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 tolerability.”

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, Canada, 
Hong Kong, China, Russia and Japan.

**Hyperkalaemia**

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**

_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 worldwide.

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