TIDMAZN
RNS Number : 8210X
AstraZeneca PLC
24 February 2017
This announcement contains inside information
24 February 2017 12:30 GMT
ZS-9 (sodium zirconium cyclosilicate) RECEIVES POSITIVE CHMP
OPINION FOR THE TREATMENT OF HYPERKALAEMIA
AstraZeneca today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has issued a positive opinion recommending the approval of
ZS-9 (sodium zirconium cyclosilicate) for the treatment of
hyperkalaemia, a serious condition characterised by high potassium
levels in the blood serum caused by cardiovascular, renal and
metabolic diseases.
The recommendation is based on data from three double-blind
placebo-controlled trials and one ongoing 12-month open-label trial
in adults with hyperkalaemia, representing over 1,600 patients
treated to date.
Results from a pivotal Phase III study showed that in patients
with hyperkalaemia, sodium zirconium cyclosilicate (oral
suspension) significantly reduced blood serum potassium to normal
levels (normokalaemia) within 48 hours, which was maintained during
12 days of maintenance therapy. Normal levels of potassium in the
blood serum were also achieved within 48 hours in an additional
study, with a higher proportion of patients maintaining
normokalaemia for up to 28 days on treatment versus placebo.
In these trials, sodium zirconium cyclosilicate was shown to
significantly lower serum potassium levels quickly and effectively
in patients with acute and chronic hyperkalaemia.(1,2)
The condition occurs in 23 to 47% of patients with chronic
kidney disease and/or chronic heart failure, both key strategic
areas of focus for AstraZeneca, and may lead to cardiac arrest and
death; with mortality being up to 30% in patients with severe
hyperkalaemia if not treated rapidly(1) . As current therapy
options are limited, sodium zirconium cyclosilicate has the
potential to address a long-standing unmet need for the fast, safe
and effective long-term treatment of hyperkalaemia.(2,3)
The CHMP's opinion will now be advanced to the European
Commission (EC) for adoption of a decision on EU-wide marketing
authorisation of the medicine. The final decision will be
applicable to all 28 European Union member countries plus Iceland,
Norway and Liechtenstein.
Sodium zirconium cyclosilicate is being developed by ZS Pharma,
a subsidiary of AstraZeneca. It is currently also under regulatory
review in Australia and by the FDA in the US, with decisions
expected in the first half of 2017.
About ZS-9 (sodium zirconium cyclosilicate)
ZS-9 (sodium zirconium cyclosilicate) is an insoluble,
non-absorbed zirconium silicate compound and acts as a highly
selective potassium-removing agent.(4) It is odourless and
tasteless. It is non-systemically absorbed, preferentially captures
potassium, and is administered orally in 5 to 10g doses mixed with
three tablespoons of water and is excreted in faeces. Clinical
trials indicate that it is stable at room temperature and has a
rapid onset of action. It has been studied in three double-blind,
placebo-controlled trials and in one ongoing 12-month open label
clinical trial in patients with hyperkalaemia, which represents
over 1,600 patients treated to date.
About Hyperkalaemia
Hyperkalaemia (high potassium levels in the blood serum) occurs
in 23 to 47% of patients with chronic kidney disease and/or chronic
heart failure, and may lead to cardiac arrest and death (mortality
up to 30% in patients with severe hyperkalaemia if not treated
rapidly).(1) Treatment with common heart medicines can also be
responsible for increases in hyperkalaemia. Current therapeutic
options are limited, leaving a high unmet medical need, in
particular for treatments with rapid onset of action, chronic use,
and no significant drug to drug interaction risk.
About AstraZeneca in Chronic Kidney Disease
Chronic kidney disease (CKD) is a key strategic area of focus
within AstraZeneca's Cardiovascular and Metabolic Diseases (CVMD)
therapy area. By leveraging our expertise in diabetes and
cardiovascular disease, AstraZeneca is able to better understand
the interplay of these conditions and CKD to advance our scientific
leadership in the cardio-renal space. Through novel therapies and
therapy combinations that target both the complications of CKD and
the underlying mechanisms of CKD progression, we are building a
portfolio to aggressively prevent, treat, manage and modify this
global public health issue.
About ZS Pharma
ZS Pharma, founded in 2008, was a publicly traded
biopharmaceutical company until it entered into an agreement with
AstraZeneca in November 2015 to be fully acquired. The transaction
completed in December 2015. ZS Pharma has been focused on using its
proprietary ion-trap technology to develop new treatments for
kidney and liver diseases that are focused on addressing unmet
needs in the medical community. For more information, please visit:
www.zspharma.com.
About AstraZeneca in Cardiovascular and Metabolic Diseases
Cardiovascular, renal and metabolic diseases are key areas of
focus for AstraZeneca as part of the company's strategy for
achieving scientific leadership and returning to growth. By
collaborating across therapeutic disciplines within the CVMD
therapy area, we are addressing the underlying disorders that drive
CVMD risk, with the goal of reducing morbidity, mortality and organ
damage through innovative therapies.
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 main therapy areas - Oncology, Cardiovascular & Metabolic
Diseases 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.
Media Enquiries
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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. AstraZeneca. "AstraZeneca strengthens Cardiovascular and
Metabolic disease portfolio with acquisition of ZS Pharma." 6
November 2015. Accessed 5 January 2017.
https://www.astrazeneca.com/media-centre/press-releases/2015/AstraZeneca-strengthens-Cardiovascular-and-Metabolic-disease-portfolio-with-acquisition-of-ZS-Pharma-06112015.html
Adrian Kemp
Company Secretary, AstraZeneca PLC
This information is provided by RNS
The company news service from the London Stock Exchange
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