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2020-03-26

AstraZeneca: Lokelma approved in Japan for the treatment of hyperkalaemia

Patients in Japan will benefit from Lokelma's rapid and sustained
potassium control

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 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.

AstraZeneca

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 (http://www.astrazeneca.com/) and follow
the Company on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca).

Contacts

For details on how to contact the Investor Relations Team, please
click here
(https://www.astrazeneca.com/investor-relations.html#Contacts). For
Media contacts, click here
(https://www.astrazeneca.com/media-centre/contacts.html).

References

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.

5. National Kidney Foundation. Clinical Update on Hyperkalemia. 2014.
Accessed 24 February 2020.
https://www.kidney.org/sites/default/files/02-10-6785_HBE_Hyperkalemia_B...

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 Lancet
2018; 392(10159):1789-858.

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