TIDMAZN
RNS Number : 6715I
AstraZeneca PLC
22 March 2018
22 March 2018 16:45 GMT
Lokelma approved in the EU for the treatment of adults with
hyperkalaemia
Patients will benefit from Lokelma's rapid reduction and
sustained control of potassium levels in the blood(4,5)
AstraZeneca today announced that the European Commission has
granted marketing authorisation for Lokelma (formerly ZS-9, sodium
zirconium cyclosilicate) for the treatment of adults with
hyperkalaemia. Hyperkalaemia is a serious condition characterised
by elevated potassium levels in the blood associated with
cardiovascular, renal and metabolic diseases.(1,2,3,4)
Lokelma is a highly-selective, oral potassium-removing agent.
The approval is supported by data from three double-blind,
placebo-controlled trials and one open-label trial, where patients
with hyperkalaemia were treated for up to 12 months. In these
trials, 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. Lokelma also
demonstrated sustained potassium control for up to one
year.(4,5)
The risk of hyperkalaemia increases significantly for patients
with chronic kidney disease (CKD) and for those who take common
life-saving medications for heart failure (HF), such as
renin-angiotensin-aldosterone system (RAAS) inhibitors, which can
increase potassium in the blood. To help prevent the recurrence of
hyperkalaemia, RAAS-inhibitor therapy is often modified or
discontinued; this can, however, compromise cardio-renal outcomes
and increase the risk of death.
Elisabeth Björk, Vice President, Head of Cardiovascular, Renal
and Metabolism, Global Medicines Development, AstraZeneca, said:
"The consequences of hyperkalaemia can be serious, even
life-threatening, and can occur in patients either with chronic
kidney disease or as a result of taking some medications for heart
failure. Today's approval of Lokelma addresses a significant unmet
need by bringing a rapid and sustained therapeutic option for
patients with hyperkalaemia."
Lokelma is currently under separate regulatory review in the US,
with a decision expected in the first half of 2018.
About Hyperkalaemia
The risk of hyperkalaemia increases significantly for patients
with CKD and for those who take common medications for 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 38 million people, respectively,
living with each condition worldwide. Hyperkalaemia may lead to
cardiac arrest and death, with mortality being up to 30% in
patients with severe hyperkalaemia, if not treated rapidly.
About 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 agent. It is administered
orally, is odourless, tasteless and stable at room temperature. It
has been studied in three double-blind, placebo-controlled trials
and in one 12-month open label clinical trial in patients with
hyperkalaemia. The recommended starting dose of Lokelma is 10g,
administered three times daily. Once normokalaemia (normal
potassium levels in the blood) has been achieved, a maintenance
dose of 5g once daily is recommended with possible titration up to
10g daily or down to 5g once every other day to maintain a normal
potassium level.
About AstraZeneca in Cardiovascular, Renal & Metabolism
Cardiovascular and metabolic diseases are a main therapy area
and a key growth platform for AstraZeneca, which is now called
Cardiovascular, Renal & Metabolism (CVRM), following the
addition of Lokelma to our portfolio of medicines.
By following the science to understand more clearly the
underlying links between the heart, kidney 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. Our ambition is to
modify or halt the natural course of these diseases and even
regenerate organs and restore function, by continuing to deliver
transformative science that improves treatment practices and CVRM
health for millions of patients worldwide.
About AstraZeneca
AstraZeneca 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 &
Metabolism and Respiratory. The Company also is selectively active
in the areas of autoimmunity, neuroscience and infection.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide.
For more information, please visit www.astrazeneca.com and
follow us on Twitter @AstraZeneca.
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References
(1) Kosiborod M, Rasmussen HS, Lavin P, et al. 'Effect of Sodium
Zirconium Cyclosilicate on Potassium Lowering for 28 Days Among
Outpatients With Hyperkalemia.' JAMA. 2014.
doi:10.1001/jama.2014.15688.
(2) Packham D, Rasmussen HS, Lavin P, et al. 'Sodium Zirconium
Cyclosilicate in Hyperkalemia.' New Engl J Med. 2015; 372:222-31.
doi:10.1056/NEJMoa1411487.
(3) Ash S, Bhupinder S, Lavin P, 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. doi:10.1038/ki.2014.382.
(4) National Kidney Foundation. 'Clinical Update on
Hyperkalemia." 2014. Accessed 5 January 2017.
https://www.kidney.org/sites/default/files/02-10-6785_HBE_Hyperkalemia_Bulletin.pdf.
(5) Fishbane S, Pergola PE, Packham DK, et al. 'Long-term
Efficacy and Safety of Sodium Zirconium Cyclosilicate for
Hyperkalemia: A 12-Month, Open-Label, Phase 3 Study'. Poster
presentation at: American Society of Nephrology Kidney Week;
November 2017; New Orleans, LA. TH-PO1112.
This information is provided by RNS
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