REG - AstraZeneca PLC - Forxiga approved in China for CKD

AstraZenecaAnnouncement

05/09/2022 07:16

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220905:nRSE1910Ya&default-theme=true

RNS Number : 1910Y  AstraZeneca PLC  05 September 2022

5 September 2022 07:05 BST

 

Forxiga approved in China for the treatment of chronic kidney disease in
patients at risk of progression with and without type-2 diabetes

 

Approval marks the first SGLT2 inhibitor approved in China for chronic kidney
disease in adult patients with and without type-2 diabetes

 

AstraZeneca's Forxiga (dapagliflozin), a sodium-glucose cotransporter 2
(SGLT2) inhibitor, has been approved in China to reduce the risk of sustained
estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease
(ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF)
in adults with chronic kidney disease (CKD) at risk of progression with and
without type-2 diabetes (T2D).

 

The approval by China's National Medical Products Administration (NMPA) is
based on positive results from the DAPA-CKD Phase III trial(1).

 

CKD is a serious, progressive condition defined by decreased kidney function
and is often associated with an increased risk of heart disease or
stroke(2-4). The condition affects 850 million people worldwide(5). However,
diagnosis rates remain low and up to 90% of patients are unaware they have the
disease(4).

 

Member of the DAPA-CKD Executive Committee, Fan Fan Hou, Southern Medical
University, Guangzhou, China, said: "With unprecedented results of DAPA-CKD,
dapagliflozin becomes the first SGLT2 inhibitor approved in China for the
treatment of chronic kidney disease. This transformational milestone brings
great hope to the 120 million subjects suffering from chronic kidney disease
in China."

 

Sir Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D,
AstraZeneca said: "In addition to AstraZeneca's commitment to drive increased
awareness, prevention and earlier diagnoses, this approval marks another
important step forward in our ambition to stop, reverse and ultimately cure
chronic kidney disease globally. We are thrilled at the opportunity to bring
Forxiga to millions of patients across the country and improve patient
outcomes."

 

The DAPA-CKD Phase III trial demonstrated that Forxiga, on top of
standard-of-care (SoC) treatment with an angiotensin-converting enzyme
inhibitor or an angiotensin receptor blocker, reduced the relative risk of
worsening of renal function, onset of ESKD, or risk of CV or renal death by
39%, the primary composite endpoint, compared to placebo (absolute risk
reduction  ARR =5.3%, p<0.0001) in patients with CKD Stages 2-4 and
elevated urinary albumin excretion. Forxiga also significantly reduced the
relative risk of death from any cause by 31% (ARR=2.1%, p=0.0035) compared to
placebo(6). The safety and tolerability of Forxiga were consistent with the
well-established safety profile of the medicine.

 

Forxiga (known as Farxiga in the US) is now approved in 100 countries around
the world including the US
(https://www.astrazeneca.com/media-centre/press-releases/2021/farxiga-approved-in-the-us-for-ckd.html)
, the European Union
(https://www.astrazeneca.com/media-centre/press-releases/2021/forxiga-approved-in-the-eu-for-ckd.html)
and Japan
(https://www.astrazeneca.com/media-centre/press-releases/2021/forxiga-approved-in-japan-for-ckd.html)
for the treatment of CKD in adults with and without T2D.

 

Notes

 

CKD
CKD is a serious, progressive condition defined by decreased kidney function
(shown by reduced estimated glomerular filtration rate (eGFR) or markers of
kidney damage, or both, for at least three months)(4). The most common causes
of CKD are diabetes, hypertension and glomerulonephritis.(7) CKD is
associated with significant patient morbidity and an increased risk of CV
events, such as heart failure (HF) and premature death(2). In its most
severe form, known as ESKD, kidney damage and deterioration of kidney function
have progressed to the point where dialysis or kidney transplantation are
required(2). The majority of patients with CKD will die from CV causes before
reaching ESKD(8). Currently in China, up to 120 million people are living
with CKD(9).

 

DAPA-CKD
DAPA-CKD was an international, multi-centre, randomised, double-blinded Phase
III trial in 4,304 patients designed to evaluate the efficacy
of Forxiga 10mg, compared with placebo, in patients with CKD Stage 2-4 and
elevated urinary albumin excretion, with and without T2D. Forxiga was given
once daily in addition to SoC. The primary composite endpoint was worsening of
renal function or risk of death (defined as a composite of an eGFR decline
≥50%, onset of ESKD or death from CV or renal cause). The secondary
endpoints included the time to first occurrence of the renal composite
(sustained ≥50% eGFR decline, ESKD or renal death), the composite of CV
death or hospitalisation for HF (hHF), and death from any cause. The trial was
conducted in 21 countries(1).( )Detailed results from the trial were
published in The New England Journal of Medicine
(https://www.nejm.org/doi/full/10.1056/NEJMoa2024816?query=main_nav_lg) (1).

 

Forxiga

Forxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor.
Research has shown Forxiga's efficacy in preventing and delaying cardiorenal
disease, while also protecting the organs - important findings given the
underlying links between the heart, kidneys and pancreas(1,10,11). Damage to
one of these organs can cause the other organs to fail, contributing to
leading causes of death worldwide, including T2D, HF and CKD(12-15).

Forxiga is approved as an adjunct to diet and exercise to improve glycaemic
control in adults with T2D and in T2D to reduce the risk of hHF or CV death
when added to SoC based on the findings of the DECLARE-TIMI 58
(https://www.astrazeneca.com/media-centre/press-releases/2018/farxiga-achieved-a-positive-result-in-the-phase-iii-declare-timi-58-trial-a-large-cardiovascular-outcomes-trial-in-17000-patients-with-type-2-diabetes-24092018.html)
Phase III CV outcomes trial(11). Forxiga is also approved for the treatment of
HFrEF
(https://www.astrazeneca.com/media-centre/press-releases/2020/farxiga-approved-in-the-us-for-the-treatment-of-heart-failure-in-patients-with-heart-failure-with-reduced-ejection-fraction.html)
and the treatment of CKD
(https://www.astrazeneca.com/media-centre/press-releases/2021/farxiga-approved-in-the-us-for-ckd.html)
based on the findings of the DAPA-HF
(https://www.astrazeneca.com/media-centre/press-releases/2019/detailed-results-from-phase-iii-dapa-hf-trial-showed-farxiga-significantly-reduced-both-the-incidence-of-cardiovascular-death-and-the-worsening-of-heart-failure-01092019.html)
and DAPA-CKD
(https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/farxiga-demonstrated-reduction-in-the-risk-of-kidney-failure-and-cardiovascular-or-renal-death-in-patients-with-ckd-in-the-phase-iii-dapa-ckd-trial.html)
Phase III trials(6,10).

DapaCare is a robust programme of clinical trials to evaluate the potential
CV, renal and organ protection benefits of Forxiga. It includes more than 35
completed and ongoing Phase IIb/III trials in more than 35,000 patients, as
well as more than 2.5 million patient-years' experience. Forxiga is currently
being tested in patients without T2D following an acute myocardial infarction
(MI) or heart attack in the DAPA-MI Phase III trial - a first of its kind,
indication-seeking registry-based randomised controlled trial(16).

AstraZeneca in CVRM

Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms
one of AstraZeneca's main disease 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 for organ protection and improving 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 CV 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 in Oncology, Rare Diseases, and BioPharmaceuticals,
including 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 (http://www.astrazeneca.com/) and follow the
Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca) .

 

References

1. Heerspink HJL, et al. Dapagliflozin in patients with chronic kidney
disease. N Engl J Med. 2020;383(15):1436-1446.

2. Centers for Disease Control and Prevention (CDC)  Internet . Chronic kidney
disease in the United States; 2019 [cited 2021 Jul 08]. Available from:
https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html.

3. Segall L, et al. Heart failure in patients with chronic kidney disease: a
systematic integrative review. Biomed Res Int. 2014;2014:937398.

4. Bikbov B, et al. Global, regional, and national burden of chronic kidney
disease, 1990-2017: a systematic analysis for the Global Burden of Disease
Study 2017. Lancet. 2020;395(10225):709-733.

5.  Jager KJ, et al. A single number for advocacy and communication-worldwide
more than 850 million individuals have kidney diseases. Nephrol Dial
Transplant. 2019;34(11):1803-1805.

6.   Heerspink H. DAPA-CKD - Dapagliflozin in Patients with Chronic Kidney
Disease. presented at: ESC Congress 2020 - The Digital Experience, 2020 August
29 - September 01.

7.   National Kidney Foundation  Internet . Kidney Disease: Causes; 2015
[cited 2022 Jun 09]. Available
from: https://www.kidney.org/atoz/content/kidneydiscauses
(https://www.kidney.org/atoz/content/kidneydiscauses) .

8.   Briasoulis A, et al. Chronic kidney disease as a coronary artery
disease risk equivalent. Curr Cardiol Rep. 2013;15(3):340.

9.   Zhang L, et al. Lancet. 2012 Mar 3;379(9818)815-22.

10.  McMurray JJV, et al. Dapagliflozin in patients with heart failure and
reduced ejection fraction. N Engl J Med 2019; 381(21):1995-2008.

11.   Wiviott SD, et al. for the DECLARE-TIMI 58 Investigators.
Dapagliflozin and cardiovascular outcomes in type-2 diabetes [article and
supplementary appendix]. N Engl J Med 2019; 380(4):347-57.

12.  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. Lancet 2017; 390(10100):1211-59.

13.   Mayo Clinic  Internet . Heart failure, 2020; [cited 2022 Jun 09].
Available
from: https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142
(https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142)
.

14.  Centers for Disease Control and Prevention (CDC)  Internet . A snapshot:
Diabetes in the United States, 2020; [cited 2022 Jun 09]. Available
from: https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html
(https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html)
.

15.  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 Internet . Heart disease & kidney disease, 2016; [cited 2022 Jun 09].
Available
from: https://www.niddk.nih.gov/health-information/kidney-disease/heart-disease
(https://www.niddk.nih.gov/health-information/kidney-disease/heart-disease) .

16.  Clinicaltrials.gov  Internet . Dapagliflozin Effects on Cardiovascular
Events in Patients With an Acute Heart Attack (DAPA-MI); [cited 2022 Jun 09].
Available from: https://clinicaltrials.gov/ct2/show/NCT04564742
(https://clinicaltrials.gov/ct2/show/NCT04564742) .

 

 

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  REAUPUMPBUPPPUC