Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of November
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Roxadustat
significantly increased haemoglobin levels for chronic kidney
disease patients with anaemia in Phase III OLYMPUS and ROCKIES
trials
8 November 2019 07:00 GMT
Roxadustat significantly increased haemoglobin levels for chronic
kidney disease patients with anaemia in Phase III OLYMPUS and
ROCKIES trials
OLYMPUS demonstrated a mean increase of 1.75g/dL
averaged
over weeks 28 to 52, compared to 0.40g/dL with placebo
ROCKIES demonstrated a mean increase of 0.77g/dL
averaged
over weeks 28 to 52, compared to 0.68g/dL with epoetin
alfa
AstraZeneca today presented detailed results from the Phase III
OLYMPUS and ROCKIES trials showing that roxadustat significantly
increased haemoglobin (Hb) levels in non-dialysis-dependent (NDD)
and dialysis-dependent (DD) patients with anaemia from chronic
kidney disease (CKD), respectively.
The OLYMPUS trial compared roxadustat to placebo while the ROCKIES
trial compared roxadustat to epoetin alfa. The results were
presented today during two oral sessions at the American Society of
Nephrology (ASN) Kidney Week 2019 in Washington, D.C.,
US.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Anaemia is a common, serious condition among
patients with chronic kidney disease. It occurs when the body has
fewer healthy red blood cells than normal and low levels of
haemoglobin, which may leave patients fatigued and short of breath.
Results from OLYMPUS and ROCKIES reinforce the potential
role that roxadustat could play in increasing haemoglobin levels
and managing anaemia, which is often underdiagnosed and
undertreated."
Steven Fishbane, MD, Zucker School of Medicine at
Hofstra/Northwell, Great Neck, New York, US and primary
investigator on the OLYMPUS and ROCKIES trials, said: "These data
demonstrated that roxadustat effectively increased haemoglobin
levels for patients with anaemia from chronic kidney disease,
including those who show signs of inflammation. Patients who
experience chronic inflammation are often more difficult to treat
than the overall chronic kidney disease patient population,
emphasising the need for new treatment options."
In the OLYMPUS trial, roxadustat demonstrated a statistically
significant improvement in Hb levels from baseline, with a mean
increase of 1.75g/dL averaged over weeks 28 to 52, compared to
0.40g/dL with placebo, the primary efficacy endpoint.
Roxadustat also improved Hb levels from baseline in a subgroup of
patients with elevated high-sensitivity C-reactive protein (hsCRP)
levels of greater than 5mg/L, with a statistically significant mean
increase of 1.73 g/dL, compared to 0.62g/dL with placebo, a
secondary endpoint. hsCRP is a protein in the blood that increases
when inflammation is present.
Overall safety findings are generally consistent with the NDD-CKD
patient population. For all patients, the most frequently
reported adverse events in the intent to treat analysis set were
end-stage renal disease, pneumonia, urinary tract infection and
hypertension. Additional serious adverse events reported were
azotaemia, sepsis, acute kidney injury and
hyperkalaemia.
In the ROCKIES trial, roxadustat demonstrated a statistically
significant improvement in Hb levels from baseline with a mean
increase of 0.77g/dL averaged over weeks 28 to 52, compared to
0.68g/dL with epoetin alfa, the primary efficacy
endpoint.
Roxadustat also improved Hb levels from baseline in a subgroup of
patients with elevated hsCRP levels of greater than 5 mg/L,
demonstrating a statistically significant improvement with a mean
increase of 0.80g/dL compared to 0.59g/dL with epoetin alfa, a
secondary endpoint. Patients treated with roxadustat used less
monthly intravenous (IV) iron (mean = 59mg) compared to those
treated with epoetin alfa (mean = 91mg) from week 36 to the end of
the study.
Adverse events with roxadustat were generally similar to those seen
in patients treated with epoetin alfa and commonly found in DD-CKD
patients. In roxadustat treated patients, the most frequently
reported adverse events were diarrhoea, hypertension, pneumonia,
headache and arteriovenous fistula thrombosis. Additional serious
adverse events reported were sepsis and acute myocardial
infarction.
Cardiovascular (CV) safety data from these trials will be reported
as part of the pooled efficacy and CV safety analyses of DD-CKD and
NDD-CKD patients from the global Phase III programme, which is
being presented in the oral late-breaking abstract session
"High-Impact Clinical Trials" at ASN Kidney Week on 8 November
2019.
Roxadustat is currently approved in China for the treatment of
anaemia in patients with CKD, regardless of whether they require
dialysis. Data from the Phase III OLYMPUS and ROCKIES trials,
together with the efficacy and pooled CV safety data from the
global Phase III programme, will form part of the regulatory
submission in the US, anticipated in Q4 2019.
About roxadustat
Roxadustat is a hypoxia-inducible factor prolyl hydroxylase
inhibitor (HIF-PHI) that promotes erythropoiesis by increasing
endogenous production of erythropoietin and improving iron
regulation and overcoming the negative impact of inflammation on
haemoglobin synthesis and red blood cell production by
downregulating hepcidin. Use of roxadustat has been shown to induce
coordinated erythropoiesis, increasing red blood cell count while
maintaining plasma erythropoietin levels within or near normal
physiologic range, in multiple subpopulations of CKD patients,
including in the presence of inflammation and without a need for
supplemental IV iron.
About the Phase III programme
FibroGen, Inc., (FibroGen) and AstraZeneca are collaborating on the
development and commercialisation of roxadustat for the treatment
of anaemia in patients with CKD in the US, China, and other global
markets. FibroGen and Astellas Pharma Inc. (Astellas) are
collaborating on the development and commercialisation of
roxadustat for the treatment of anaemia in patients with CKD in
territories including Japan, Europe, the Commonwealth of
Independent States, the Middle East, and South Africa.
The global Phase III programme consisted of seven trials in more
than 9,000 patients and was conducted by AstraZeneca, FibroGen and
Astellas.
About OLYMPUS
OLYMPUS is a Phase III, randomised, double blind,
placebo-controlled trial designed to evaluate the efficacy and
safety of roxadustat vs. placebo for the treatment of NDD patients
with anaemia from CKD stages 3, 4 and 5 . OLYMPUS evaluated 2,781
patients with anaemia (Hb<10.0g/dL) in NDD-CKD stages 3-5 who
were randomised 1:1 to roxadustat or placebo across 26 countries.
Top-line results announced in December 2018 showed OLYMPUS met its
primary efficacy endpoint. OLYMPUS is one of two
AstraZeneca-sponsored trials that are part of the global Phase III
clinical trials programme.
About ROCKIES
ROCKIES is a Phase III, randomised, open-label, active-controlled
trial designed to assess the efficacy and safety of roxadustat vs.
epoetin alfa, for the treatment of patients with anaemia in DD-CKD.
ROCKIES evaluated 2,133 DD-CKD patients with anaemia either
currently treated with an erythropoietin analogue (Hb<12g/dL) or
not currently treated with an erythropoietin analogue
(Hb<10g/dL) randomised 1:1 to roxadustat or epoetin alfa across
18 countries. Oral iron was allowed; IV iron was used as standard
of care (SoC) in the epoetin alfa arm and with evidence of iron
deficiency in the roxadustat arm. Top-line results announced in
December 2018 showed ROCKIES met its primary efficacy endpoint.
ROCKIES is one of two AstraZeneca-sponsored trials that are part of
the global Phase III clinical trials programme.
About anaemia from CKD
Anaemia can be a serious medical condition in which patients have
insufficient red blood cells and low levels of haemoglobin, a
protein in red blood cells that carries oxygen to cells throughout
the body.1,2 Anaemia
from CKD is associated with increased risk of hospitalisation, CV
complications and death,3 also
frequently causing significant fatigue, cognitive dysfunction and
decreased quality of life.4 Severe
anaemia is common in patients with CKD, cancer, myelodysplastic
syndrome, inflammatory diseases and other serious
illnesses.
Anaemia is particularly prevalent in patients with CKD. CKD affects
more than 200 million patients worldwide and is generally a
progressive disease characterised by gradual loss of kidney
function that may eventually lead to kidney failure.
According to the United States Renal Data System, about 80% of the
approximately 507,000 patients receiving dialysis in the US in 2016
were being treated with erythropoiesis-stimulating agents
(ESA).5 Patients
seldom receive ESA treatment until they initiate dialysis
therapy.
About AstraZeneca in CVRM
Cardiovascular, Renal & 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.
About AstraZeneca
AstraZeneca 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, CVRM, and Respiratory. AstraZeneca
operates in over 100 countries, and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Media
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References
1.
National Kidney Foundation. "Managing Anaemia When You Have Kidney
Disease or Kidney Failure." 2014.
2.
National Institute of Diabetes and Digestive and Kidney Diseases.
"Anaemia in Chronic Kidney Disease." 2014.
3.
Babitt JL, Lin HY. Mechanisms of Anemia in CKD. J Am Soc Nephrol
(2012); 23:1631-1634.
4.
KDOQI Clinical Practice Guidelines and Clinical Practice
Recommendations for Anaemia in Chronic Kidney
Disease. Am J Kidney
Dis. 2006 May; 47(5): S1-S132.
5. United States Renal
Data System. "Annual Data Report." 2017.
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
08 November
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|