TIDMAZN
RNS Number : 7220S
AstraZeneca PLC
08 November 2019
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.
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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
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