TIDMAZN
RNS Number : 9311A
AstraZeneca PLC
02 October 2020
2 October 2020 07:00 BST
Farxiga granted Breakthrough Therapy Designation
in US for chronic kidney disease
Designation follows DAPA-CKD Phase III trial results in which
Farxiga demonstrated unprecedented reduction in the risk of kidney
failure and cardiovascular or renal death in patients with chronic
kidney disease
AstraZeneca's Farxiga (dapagliflozin) has been granted
Breakthrough Therapy Designation (BTD) in the US for patients with
chronic kidney disease (CKD), with and without type-2 diabetes
(T2D).
CKD is a serious, progressive condition defined by decreased
kidney function and is often associated with an increased risk of
heart disease or stroke.(1,2,3) In the US, 37 million people are
estimated to have CKD.(1)
The Food and Drug Administration (FDA)'s BTD is designed to
accelerate the development and regulatory review of potential new
medicines that are intended to treat a serious condition and
address a significant unmet medical need. The new medicine needs to
have shown encouraging early clinical results that demonstrate
substantial improvement on a clinically significant endpoint over
available medicines.(4)
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "There is a serious, unmet need for better and
earlier treatment options for patients with chronic kidney disease.
Following the ground-breaking DAPA-CKD results, the Breakthrough
Therapy Designation is further testament to Farxiga's potential to
slow the progression of chronic kidney disease. We look forward to
working with the FDA to make Farxiga available to patients as
quickly as possible."
The FDA granted BTD based on clinical evidence from the DAPA-CKD
trial. The detailed results presented in August demonstrated that
Farxiga on top of standard of care reduced the composite measure of
worsening of renal function or risk of cardiovascular (CV) or renal
death by 39% compared to placebo (absolute risk reduction [ARR] =
5.3%, p<0.0001) in patients with CKD while also significantly
reducing death from any cause by 31% (ARR = 2.1%, p=0.0035)
compared to placebo.(5)
In the US, Farxiga is indicated as an adjunct to diet and
exercise to improve glycaemic control in adults with T2D and to
reduce the risk of hospitalisation for heart failure (hHF) in
patients with T2D and established CV disease or multiple CV risk
factors. In May, Farxiga was approved in the US to reduce the risk
of CV death and hHF in adults with heart failure (HF) (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) affecting nearly 700 million people worldwide, many
of them still undiagnosed.(3,6-8) 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,(3) such as HF and premature death.(2) 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 is an international, multi-centre, randomised,
double-blinded trial in 4,304 patients designed to evaluate the
efficacy of Farxiga 10mg, compared with placebo, in patients with
CKD Stages 2-4 and elevated urinary albumin excretion, with and
without T2D. Farxiga is given once daily in addition to standard of
care. The primary composite endpoint is 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 and detailed results were
announced in August 2020 .
Farxiga
Farxiga (dapagliflozin) is a first-in-class, oral, once-daily
sodium-glucose co-transporter-2 inhibitor indicated in adults for
the treatment of insufficiently controlled T2D as both monotherapy
and as part of combination therapy as an adjunct to diet and
exercise to improve glycaemic control, with the additional benefits
of weight loss and blood-pressure reduction. In the DECLARE CV
outcomes trial in adults with T2D, Farxiga reduced the risk of the
composite endpoint of hHF or CV death versus placebo, when added to
standard of care.
Farxiga is currently being tested for patients with HF in the
DELIVER (HF with preserved ejection fraction, HFpEF) and DETERMINE
(HFrEF and HFpEF) trials. Farxiga will also be tested in patients
without T2D following an acute myocardial infarction (MI) or heart
attack in the DAPA-MI trial - a first of its kind,
indication-seeking registry-based randomised controlled trial.
Farxiga has a robust programme of clinical trials that 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.
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. Centers for Disease Control and Prevention. Chronic Kidney
Disease in the United States, 2019 [cited 01.05.20]. 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. The Lancet 2020;
395(10225):709-33.
4. U.S. Food and Drug Administration. Frequently Asked
Questions: Breakthrough Therapies [cited 2020 Sep 28]. Available
from: URL:
https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies
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. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work
Group. KDIGO 2012 clinical practice guideline for the evaluation
and management of chronic kidney disease. Kidney International
Supplement 2013; (3):1-150.
7. Hirst JA et al. Prevalence of chronic kidney disease in the
community using data from OxRen: A UK population-based cohort
study. Br J Gen Pract 2020; 70(693):e285-e293.
8. National Kidney Foundation. Kidney Disease: The Basics; 2020
[cited 2020 Sep 23]. Available from: URL:
https://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics
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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