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2020-03-31

AstraZeneca: Lokelma recommended for approval in EU for patients with hyperkalaemia on stable haemodialysis

Label update is based on data from Phase IIIb DIALIZE trial

The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion on a
dosing and administration label update for AstraZeneca's Lokelma
(sodium zirconium cyclosilicate) to include patients with
hyperkalaemia on stable haemodialysis.

The recommendation was based on data from the Phase IIIb DIALIZE
trial, which showed a significant reduction in potassium levels
pre-dialysis for patients receiving Lokelma, compared with
placebo.[1]

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said:
"Despite being on dialysis, many patients with renal disease still
have high potassium levels, which can be life-threatening if left
untreated. This recommendation underscores the clinical value that
Lokelma could provide to physicians and patients who are looking to
normalise potassium levels between dialysis sessions."

In DIALIZE, 41% of patients receiving Lokelma maintained pre-dialysis
potassium levels on at least three out of four dialysis treatments
after the long interdialytic interval and did not require urgent
rescue therapy. This compared with 1.0% of patients receiving
placebo, making it a statistically significant and clinically
meaningful improvement. The safety profile of Lokelma observed in
DIALIZE was consistent with previous trials.[1]

Lokelma is a highly selective, oral potassium-removing agent currently
approved in the US, EU, Canada, Hong Kong, China, Russia and Japan
for the treatment of hyperkalaemia.

Hyperkalaemia

Hyperkalaemia is characterised by high levels of potassium in the
blood, generally classified as greater than 5mmol/l.[2] Many people
living with chronic kidney disease (CKD) have hyperkalaemia despite
being on haemodialysis and often experience fluctuations in their
potassium levels.[3,4] Patients with high variability in potassium
levels between dialysis sessions are at significant risk of
arrhythmias which can lead to cardiac arrest.[3] Hyperkalaemia occurs
in 23% to 47% of patients with CKD and/or heart failure with an
estimated 700 million and 64 million people, respectively, living
with each condition worldwide.[5,6]

DIALIZE

DIALIZE is the first ever randomised, placebo-controlled trial to
evaluate a potassium binder in patients on stable haemodialysis. The
Phase IIIb, multicentre, double-blinded trial investigated the
efficacy of Lokelma versus placebo in 196 patients on haemodialysis
with hyperkalaemia. Patients were randomised to receive Lokelma or
placebo once daily on non-dialysis days for a treatment period of
eight weeks. This included a four-week dose adjustment phase
(starting at 5g and titrated weekly in 5g increments up to a maximum
of 15g) and a four-week evaluation phase on stable dose.

The full results of the DIALIZE trial were published in September 2019
in the Journal of the American Society of Nephrology.
(https://jasn.asnjournals.org/content/early/2019/06/13/ASN.2019050450)

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
studied in three double-blinded, placebo-controlled trials and in one
12-month open label clinical 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 comorbidities. 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. Fishbane S et al. A Phase 3b, Randomized, Double-Blind,
Placebo-Controlled Study of Sodium Zirconium Cyclosilicate for
Reducing the Incidence of Predialysis Hyperkalemia. J Am Soc Nephrol
2019.

2. Kovesdy CP. Management of hyperkalaemia in chronic kidney disease.
Nat Rev Nephrol. Nov 2014; 10:653-662.

3. Kovesdy CP. et al. Serum and Dialysate Potassium Concentrations and
Survival in Hemodialysis Patients. Clin J Am Soc Nephrol.
2007:2:999-1007.

4. Evans KJ, Greenberg A. Hyperkalemia: A review. J Intensive Care
Med. 2005;20:272-290.

5. 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(10100):1211-59.

6. 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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