TIDMAZN
RNS Number : 8101Y
AstraZeneca PLC
06 January 2020
6 January 2020 07:00 GMT
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.
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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
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and cardiovascular health for millions of patients worldwide.
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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_Bulletin.pdf
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.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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