TIDMAZN
RNS Number : 7318K
AstraZeneca PLC
06 January 2021
6 January 2021 07:00 GMT
Farxiga granted Priority Review in the US
for the treatment of patients with chronic kidney disease
Farxiga could become the first SGLT2 inhibitor approved to
treat
patients with chronic kidney disease, with and without type-2
diabetes
AstraZeneca's Farxiga (dapagliflozin) has been granted Priority
Review in the US for the treatment of new or worsening chronic
kidney disease (CKD) in adults with and without type-2 diabetes
(T2D).
The Food and Drug Administration (FDA) grants Priority Review to
regulatory submissions for medicines that offer significant
advances over available options by demonstrating safety or efficacy
improvements, preventing serious conditions, or enhancing patient
compliance. The Prescription Drug User Fee Action date, the day the
FDA targets for their regulatory decision, will be during the
second quarter of 2021.
CKD, a condition defined by decreased kidney function, is often
associated with a heightened risk of heart disease or stroke, or
the need for dialysis or kidney transplant.(1-3) CKD is expected to
become the world's fifth leading cause of mortality by 2040.(4)
Currently in the US, 37 million people are estimated to have
CKD.(1)
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "This decision brings us a step closer to delivering
this new treatment option for the millions of patients living with
chronic kidney disease in the US. Farxiga has the potential to be a
truly transformational medicine across a breadth of diseases,
including type-2 diabetes, heart failure with reduced ejection
fraction and, if approved, chronic kidney disease."
The acceptance of the regulatory submission by the FDA and the
granting of Priority Review was based on clinical evidence from the
DAPA-CKD Phase III trial. The trial showed that Farxiga, on top of
standard of care consisting of an angiotensin-converting enzyme
inhibitor (ACEi) or an angiotensin receptor blocker (ARB), reduced
the risk of the composite of worsening of renal function or risk of
cardiovascular (CV) or renal death by 39%, the primary 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. It also significantly reduced the risk of death
from any cause by 31% (ARR 2.1%, p=0.0035) compared to placebo.(5)
The safety and tolerability of Farxiga were consistent with the
well-established safety profile of the medicine.
In March 2020, an independent Data Monitoring Committee
recommended the trial be stopped early, based on its determination
of overwhelming efficacy. Detailed results from the DAPA-CKD trial
were shared in August 2020 and published in The New England Journal
of Medicine .(6)
In October 2020 , Farxiga received Breakthrough Therapy
Designation in the US for patients with CKD with and without T2D.
In the US, Farxiga is indicated as an adjunct to diet and exercise
to improve glycaemic control in adults with T2D. In May 2020
Farxiga was approved in the US to reduce the risk of CV death and
hospitalisation for heart failure (hHF) in adults with heart
failure (NYHA class II-IV) with reduced ejection fraction (HFrEF)
with and without T2D.
Chronic kidney disease
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)(7) affecting nearly 850 million people worldwide,
many of them still undiagnosed.(8) The most common causes of CKD
are diabetes, hypertension and glomerulonephritis.(9) CKD is
associated with significant patient morbidity and an increased risk
of CV events, such as heart failure (HF) and premature death. In
its most severe form, known as end-stage kidney disease (ESKD),
kidney damage and deterioration of kidney function have progressed
to the stage where dialysis or kidney transplantation are
required.(1) The majority of patients with CKD will die from CV
causes before reaching ESKD.(10)
DAPA-CKD
DAPA-CKD was an international, multi-centre, randomised,
double-blinded trial in 4,304 patients designed to evaluate the
efficacy of dapagliflozin 10mg, compared with placebo, in patients
with CKD Stages 2-4 and elevated urinary albumin excretion, with
and without T2D. Farxiga was given once daily in addition to
standard of care consisting of an ACEi or an ARB. 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
and death from CV or renal cause). The secondary endpoints included
the time to first occurrence of the renal composite (sustained
>=50% eGFR decline, ESKD and renal death), the composite of CV
death or hHF, and death from any cause. The trial was conducted in
21 countries.(6)
Farxiga
Farxiga (dapagliflozin) is a first-in-class, oral, once-daily
sodium-glucose co-transporter-2 (SGLT2) inhibitor.
The research for Farxiga 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 Farxiga 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. Farxiga 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 Farxiga achieved unprecedented reduction in the
composite risk of kidney failure and CV or renal death in patients
with CKD versus placebo, and is now the first SGLT2 inhibitor shown
to significantly prolong survival in a renal outcomes trial for
this patient population and provide organ protection. Farxiga is
not indicated for the treatment of CKD.
DapaCare is a robust programme of clinical trials to evaluate
the potential CV, renal and organ protection benefits of Farxiga.
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. Farxiga 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) 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 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 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. Centers for Disease Control and Prevention (CDC). Chronic
Kidney Disease in the United States, 2019; 11 March 2019 [cited 22
October 2020]. 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):709-33.
4. Foreman KJ et al. Forecasting Life Expectancy, Years of Life
Lost, and All-Cause and Cause-Specific Mortality for 250 Causes of
Death: Reference and Alternative Scenarios for 2016-40 for 195
Countries and Territories. Lancet 2018; 392:2052-90.
5. Heerspink H. DAPA-CKD - Dapagliflozin in Patients with
Chronic Kidney Disease. presented at: ESC Congress 2020 - The
Digital Experience, 2020 August 29 - September 01.
6. Heerspink HJL et al. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med 2020; 383(15):1436-46.
7. Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work
Group. KDIGO Clinical Practice Guideline for Anemia in Chronic
Kidney Disease. Kidney International Supplement 2012;
2:279-335.
8. 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):1803-5.
9. National Kidney Foundation. Kidney Disease: Causes; 2015
[cited 2020 Sep 23]. Available from: URL:
https://www.kidney.org/atoz/content/kidneydiscauses
10. Briasoulis A, Bakris GL. Chronic Kidney Disease as a
Coronary Artery Disease Risk Equivalent. Current Cardiology Reports
2013; 15(3):340.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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