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2020-01-06

AstraZeneca: Lokelma approved in China for the treatment of adult patients with hyperkalaemia

Patients in China will benefit from Lokelma's rapid reduction of
potassium in the blood and the sustained treatment effect

AstraZeneca's Lokelma (sodium zirconium cyclosilicate) has been
approved in China for the treatment of adult patients with
hyperkalaemia (elevated levels of potassium in the blood).

The approval by the National Medical Products Administration (NMPA)
was based on positive results from the extensive Lokelma clinical
trial programme and a pharmacodynamic study in China which showed
that patients receiving Lokelma experienced a significant, rapid and
sustained reduction of potassium in the blood.

In 2019, the NMPA included Lokelma on the Accelerated Approval list of
"Overseas New Drugs in Clinical Urgent Needs for China", recognising
the significant unmet need for effective medicines treating
hyperkalaemia.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said:
"This approval marks an important milestone for more than two million
patients in China who suffer from hyperkalaemia. Lokelma will offer
the opportunity for patients and physicians to achieve long-term
disease control and potentially reduce the risk of acute episodes,
which can have serious, even life-threatening consequences."

The Lokelma clinical trials programme includes three double-blinded,
placebo-controlled trials and one open-label trial, where patients
with hyperkalaemia were treated for up to 12 months. These trials
showed that for patients receiving Lokelma, 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.[1-3]
Lokelma also 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.[1,2,4] Lokelma was well tolerated, with few
serious adverse events.[2]

Lokelma is approved in the US, the EU and Canada for the treatment of
hyperkalaemia. It is undergoing separate regulatory review in Japan,
with a decision expected in the first half of 2020.

Hyperkalaemia

Hyperkalaemia is characterised by high levels of potassium in the
blood (generally classified as >5mmol/l).[1] 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 RAAS inhibitors, which can increase
potassium in the blood. Hyperkalaemia occurs in 23% to 47% of
patients with CKD and/or HF, with an estimated 200 million and 64
million people, respectively, living with each condition
worldwide.[5-7] Hyperkalaemia may lead to cardiac arrest and death,
with mortality being up to 30% in patients with severe hyperkalaemia,
if not treated rapidly.[8]

Lokelma

Lokelma 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. It has been
evaluated in three double-blinded, placebo-controlled trials and in
one 12-month open-label trial in patients with hyperkalaemia.

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. 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).

Media Relations
Gonzalo Viña +44 203 749 5916
Rob Skelding Oncology +44 203 749 5821
Rebecca Einhorn Oncology +1 301 518 4122
Matt Kent BioPharmaceuticals +44 203 749 5906
Angela Fiorin BioPharmaceuticals +44 122 334 4690
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Investor
Relations
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Larsen
Henry Wheeler Oncology +44 203 749 5797
Christer BioPharmaceuticals +44 203 749 5711
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Environmental, Social and
Governance
Josie Afolabi BioPharmaceuticals +44 203 749 5631
(Respiratory) Other medicines
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Kretzmann investors
US toll-free +1 866 381 72 77

References

1. AstraZeneca. Lokelma Prescribing Information. December 2019.
2. 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 Jun 7;14(6):798-809.

3. National Kidney Foundation. Clinical Update on Hyperkalemia. 2014.
Accessed 17 December 2019.
https://www.kidney.org/sites/default/files/02-10-6785_HBE_Hyperkalemia_B...

4. 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.

5. Latts et al. Hyperkalemia Is Prevalent in Patients with
Cardiorenal Comorbidities. Presented at the ISPOR 20th Annual
International Meeting, May 16-20, 2015, Philadelphia, PA.

6. Ojo, A. Addressing the Global Burden of Chronic Kidney Disease
Through Clinical and Translational Research. Trans Am Clin Climatol
Assoc. 2014; 125:229-246.

7. 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.

8. Dunn J, et al. The burden of hyperkalaemia in patients with
cardiovascular and renal disease. Am J Manag Care. 2015;21(15
Suppl)307-15.

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