Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON

MarketScreener Homepage  >  Equities  >  London Stock Exchange  >  AstraZeneca PLC    AZN   GB0009895292

ASTRAZENECA PLC

(AZN)
  Report
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector newsMarketScreener Strategies

AstraZeneca : Lokelma label update approved in China for patients with hyperkalaemia on chronic haemodialysis; Label update is based on data from Phase IIIb DIALIZE trial

11/25/2020 | 04:40am EST

The National Medical Products Administration (NMPA) has approved a dosing label update in China for AstraZeneca's Lokelma (sodium zirconium cyclosilicate) to include patients with hyperkalaemia on chronic haemodialysis.

The approval by the NMPA was based on data from the Phase IIIb DIALIZE trial, the first ever randomised, placebo-controlled trial to evaluate a potassium binder in patients on stable haemodialysis. The trial showed sustained potassium control pre-dialysis for more patients receiving Lokelma, compared with placebo.1

Lokelma was approved for the treatment of adult patients with hyperkalaemia in China by the NMPA in December 2019.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "In China, more than 550,000 patients with chronic kidney disease on haemodialysis are at risk of developing hyperkalaemia,2 which can in turn lead to arrythmias and cardiac arrest. Today's label update provides guidance to manage hyperkalaemia in this high-risk patient population, potentially enabling improved long-term treatment and overall kidney care."

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% of patients receiving placebo, making it a statistically significant and clinically meaningful improvement (p5.5 mmol/L.8 Patients with high variability in potassium levels between dialysis sessions are at significant risk of arrhythmias, which can lead to cardiac arrest.4 Worldwide, there are an estimated 700 million and 64 million people living with CKD and HF respectively with hyperkalaemia occurring in 23 to 47% of patients with advanced CKD (stage 3-4) and/or HF.9-11

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 and safety 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.

Lokelma

Lokelma (sodium zirconium cyclosilicate) 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.12.13 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 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/Nasdaq: 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 & Metabolism, and Respiratory & Immunology. 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 and follow the Company on Twitter @AstraZeneca.

Contacts

For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.

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. Wang F et al. Executive summary for the 2015 Annual Data Report of the China Kidney Disease Network (CK-NET). Kidney International 2019; 95(3):501-5.

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

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

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

6. Kramer A et al. The European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Registry Annual Report 2016: A summary. Clinical Kidney Journal 2019; 12(5):702-20.

7. United States Renal Data System. 2018 Annual Data Report Volume 2: End-Stage Renal Disease Chapter 1: Incidence, Prevalence, Patient Characteristics, and Treatment Modalities. https://www.usrds.org/2018/view/v2_01.aspx. Published 2018. Accessed 1 May 2020.

8. Xu H et al. Prevalence of hyperkalemia in DOPPS: A real-world, international cohort of hemodialysis patients (MP371). presented at: ERA-EDTA Annual Congress 2017, 2019 Jun 3-6, Madrid, Spain..

9. 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 Lancet2017; 390(10100):1211-59.

10. 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.

11. Latts LM et al. Hyperkalemia Is Prevalent in Patients with Cardiorenal Comorbidities. presented at: ISPOR 20th Annual International Meeting, 2015 May 16 - 20, Philadelphia PA.

12. LOKELMA® (sodium zirconium cyclosilicate) US Prescribing Information; last update: Oct 2020 [cited 23 Nov 2020]. Available from: URL: https://www.azpicentral.com/lokelma/lokelma.pdf.

13. Kosiborod M et al. Effect of sodium zirconium cyclosilicate on potassium lowering for 28 days among outpatients with hyperkalemia: The HARMONIZE randomized clinical trial. JAMA 2014; 312(21):2223-33.

Approval ID: Z4-29004 | Date of Preparation: November 2020

.

(C) 2020 M2 COMMUNICATIONS, source M2 PressWIRE

All news about ASTRAZENECA PLC
04:50aSanofi to Collaborate With BioNTech on Coronavirus Vaccine Production -- Upda..
DJ
03:41aASTRAZENECA : is recognised as a Top Employer 2021 in South Africa and Kenya
AQ
03:15aBill Gates sees 6-8 month lag for poor countries to get COVID-19 shots
RE
03:10aASTRAZENECA : is recognised as a Top Employer 2021 in South Africa and Kenya Bei..
AQ
01/26ASTRAZENECA : Two Months Behind COVID-19 Vaccine Production Schedule in EU, CEO ..
MT
01/26ASTRAZENECA : Faces Lawsuit Over COVID-19 Vaccine Testing Debacle
MT
01/26MARKET CHATTER : Japan to Buy 20,000 Freezers for $96 Million to Store COVID-19 ..
MT
01/26ASTRAZENECA : Global COVID-19 cases surpass 100 million as nations tackle vaccin..
RE
01/26ASTRAZENECA : Peru orders total lockdown across 10 states as second wave bites
RE
01/26ROBBINS GELLER RUDMAN & DOWD LLP : Files Class Action Suit Against AstraZeneca p..
BU
More news
Financials (USD)
Sales 2020 26 379 M - -
Net income 2020 2 956 M - -
Net Debt 2020 13 464 M - -
P/E ratio 2020 43,7x
Yield 2020 2,58%
Capitalization 143 B 143 B -
EV / Sales 2020 5,95x
EV / Sales 2021 5,13x
Nbr of Employees 70 600
Free-Float 95,7%
Chart ASTRAZENECA PLC
Duration : Period :
AstraZeneca PLC Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends ASTRAZENECA PLC
Short TermMid-TermLong Term
TrendsNeutralBearishNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 25
Average target price 127,03 $
Last Close Price 109,27 $
Spread / Highest target 43,8%
Spread / Average Target 16,3%
Spread / Lowest Target -17,4%
EPS Revisions
Managers and Directors
NameTitle
Pascal Soriot Chief Executive Officer & Executive Director
Leif Valdemar Johansson Non-Executive Chairman
Pam P. Cheng Executive VP-Operations & Information Technology
Marc Pierre Jean Dunoyer Chief Financial Officer & Executive Director
Menelas N. Pangalos EVP-Biopharmaceuticals Research & Development
Sector and Competitors
1st jan.Capitalization (M$)
ASTRAZENECA PLC8.57%143 360
JOHNSON & JOHNSON8.32%448 796
ROCHE HOLDING AG4.51%312 213
NOVARTIS AG0.81%214 457
PFIZER INC.1.36%207 384
MERCK & CO., INC.-1.89%203 035