TIDMAZN
RNS Number : 2364D
AstraZeneca PLC
28 June 2021
28 June 2021 07:05 BST
Forxiga recommended for approval in the EU by CHMP
for the treatment of patients with chronic kidney disease
If approved, Forxiga has the potential to change the treatment
paradigm
for millions of people in the EU suffering from chronic kidney
disease
AstraZeneca's Forxiga (dapagliflozin) has been recommended for
approval in the European Union (EU) for the treatment of chronic
kidney disease (CKD) in adults with and without type-2 diabetes
(T2D).
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency based its positive opinion on results
from the DAPA-CKD Phase III trial that showed Forxiga, on top of
standard-of-care treatment with an angiotensin-converting enzyme
inhibitor or an angiotensin receptor blocker, reduced the risk of
the composite of worsening of renal function, end-stage kidney
disease (ESKD) and cardiovascular (CV) or renal death, compared to
placebo.
Forxiga also significantly reduced the risk of death from any
cause, compared to placebo. In the trial, the safety and
tolerability of Forxiga were consistent with the well-established
safety profile of the medicine.
CKD is a serious, progressive condition defined by decreased
kidney function and is often associated with an increased risk of
heart disease or stroke.(1-3) It affects approximately 47 million
people in the EU and nearly 840 million people worldwide.(3,4)
However, diagnosis rates remain low and up to 90% of patients are
unaware they have the disease.(5)
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "The unprecedented results of the DAPA-CKD Phase III
trial show that Forxiga can significantly slow the decline of
kidney function and reduce the risk of death for patients with
chronic kidney disease. This positive CHMP opinion underscores
Forxiga's potential to transform the future care of chronic kidney
disease and brings us one step closer to providing a much-needed
new treatment option to millions of patients in the EU."
Forxiga (known as Farxiga in the US) was recently approved in
the US for the treatment of CKD in adults with and without T2D and,
in addition to the EU, is currently under review in Japan and other
countries around the world. Forxiga is also indicated as an adjunct
to diet and exercise to improve glycaemic control in adults with
T2D and for the treatment of symptomatic chronic heart failure (HF)
with reduced ejection fraction (HFrEF) in adults with and without
T2D.
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).(3) The most common causes of CKD are diabetes,
hypertension and glomerulonephritis.(6) CKD is associated with
significant patient morbidity and an increased risk of CV events,
such as HF and premature death. 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.(1) The majority of patients with CKD will die from CV
causes before reaching ESKD.(7)
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
standard of care. 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.(8) Detailed results from the trial were published in The
New England Journal of Medicine .(8)
Forxiga
Forxiga (dapagliflozin) is a first-in-class, oral, once-daily
sodium-glucose cotransporter 2 (SGLT2) inhibitor. The research for
Forxiga is advancing from cardiorenal effects to prevention and
organ protection as science continues to identify the underlying
links between the heart, kidneys and pancreas. 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.
For nearly a decade Forxiga has been an effective monotherapy
and part of combination therapy as an adjunct to diet and exercise
to improve glycaemic control in adults with T2D. Following results
from the landmark DECLARE-TIMI 58 Phase III CV outcomes trial, it
is approved in adults with T2D to reduce the risk of hHF or CV
death when added to standard of care.(9) Forxiga is also the first
SGLT2 inhibitor approved for the treatment of HFrEF in adults with
and without T2D.
In August 2020, results from the DAPA-CKD Phase III trial
demonstrated that Forxiga achieved unprecedented reduction in the
composite risk of kidney failure and CV or renal death in patients
with CKD with and without T2D versus placebo.(8) It is now the
first SGLT2 inhibitor approved for the treatment of CKD regardless
of diabetes status.
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. It is currently being assessed in
patients with HF with preserved ejection fraction in the DELIVER
Phase III trial. Forxiga is also 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.
AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM), part of
BioPharmaceuticals, forms one of AstraZeneca's three 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 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 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 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 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. Centers for Disease Control and Prevention. Chronic kidney
disease in the United States, 2021; 2021 [cited 2021 Jun 1].
Available from: URL:
https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html
.
2. Segall L, et al. Heart failure in patients with chronic
kidney disease: a systematic integrative review. Biomed Res Int.
2014;2014:937398.
3. 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.
4. 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.
5. National Kidney Foundation. Kidney Disease: The Basics; 2021
[cited 2021 Jun 1]. Available from: URL:
https://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics
.
6. National Kidney Foundation. Kidney Disease: Causes; 2015
[cited 2021 Jun 1]. Available from: URL:
https://www.kidney.org/atoz/content/kidneydiscauses .
7. Briasoulis A, Bakris GL. Chronic kidney disease as a coronary
artery disease risk equivalent. Curr Cardiol Rep.
2013;15(3):340.
8. Heerspink HJL, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020;383(15):1436-1446.
9. 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.
2019:380:347-357.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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