TOKYO and SAN FRANCISCO,
Jan. 30, 2020 /PRNewswire/
-- Astellas Pharma Inc. (TSE: 4503, President and CEO:
Kenji Yasukawa, Ph.D., "Astellas")
and FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, "FibroGen") today announced
the submission of a supplemental New Drug Application (sNDA) to
Japan's Ministry of Health, Labour
and Welfare to gain marketing approval for Evrenzo®
(generic name: roxadustat) for the treatment of anemia associated
with chronic kidney disease (CKD) in non-dialysis dependent
(NDD) patients. Roxadustat was approved in Japan for the treatment of anemia associated
with CKD in dialysis dependent (DD) patients in September 2019 and launched for use in this
indication in November 2019.
The sNDA for the use of roxadustat in NDD-CKD patients is
supported by three studies in more than 500 Japanese patients,
which establish the profile within this group of
patients.1,2,3 The first, an open-label Phase 3
conversion study versus active comparator, darbepoetin alfa
(genetical recombination) ("darbepoetin alfa"), met the
primary efficacy endpoint of non-inferiority and continued to
demonstrate maintenance of hemoglobin (Hb) levels over
time.1 Roxadustat was well tolerated and the safety
profile of roxadustat was comparable to that of darbepoetin
alfa.1 The other two studies (one Phase
3 and one Phase 2) support the safety and efficacy in patients
naïve to erythropoiesis-stimulating
"The data demonstrates that roxadustat is effective in
increasing and maintaining Hb levels within the target range in
patients with anemia associated with CKD who are not on dialysis,"
said Bernhardt G Zeiher, M.D., Chief Medical Officer, Astellas.
"This submission is an important next step to bringing roxadustat
to even more patients with this condition in Japan, and this is particularly pertinent in
the non-dialysis setting where many patients' anemia is currently
not treated, or not treated to target."
"We are excited to reach another important milestone for
roxadustat and appreciate the joint team's commitment to addressing
the significant unmet medical need of patients living with anemia
associated with CKD," said K Peony Yu, M.D., Chief Medical Officer,
About Clinical Trials
For more information about the clinical trials associated with this
(1517-CL-0310,1 1517-CL-0314,2 1517-CL-03033),
please visit www.clinicaltrials.gov.
About CKD and Anemia
CKD is a progressive loss of kidney function caused by damage to
the kidneys resulting from conditions such as hypertension,
diabetes or immune-regulated inflammatory conditions.4
Worldwide, 1 in 10 people are living with CKD.5 In
Japan, specifically, the
prevalence of CKD has increased significantly over
time.6 CKD is predicted to become the fifth most common
cause of premature death globally by 2040.7 It is a
critical worldwide healthcare issue that represents a large and
growing unmet medical need.
Anemia is a common early complication of
CKD,8 affecting approximately 20% of patients with
CKD.9 It results from the failing kidneys' diminished
ability to produce erythropoietin, which stimulates red blood cell
production from the bone marrow. It is associated with significant
morbidity and mortality in dialysis and non-dialysis populations,
increasing in both prevalence and severity as kidney disease
worsens.10 Anemia associated with CKD increases the risk
of adverse cardiovascular events, worsens renal outcomes and can
negatively impact patients' quality of life.10,11,12
Roxadustat is a first-in-class orally administered inhibitor of
hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) that
corrects anemia by a mechanism of action that is different from
that of ESAs. As a HIF-PH inhibitor, roxadustat activates a
response that occurs naturally when the body responds to reduced
oxygen levels in the blood. The response activated by roxadustat
involves the regulation of multiple, complementary processes to
promote erythropoiesis and increase the blood's oxygen-carrying
capacity. Roxadustat is approved and launched for the treatment of
anemia associated with CKD in Japan in DD patients and in China in both DD and NDD patients. An NDA has
been submitted in the US. Also, roxadustat is in Phase 2 for
Astellas Pharma Inc., and FibroGen, Inc. are collaborating on
the development of roxadustat for the potential treatment of anemia
in territories including Japan,
Europe, the Commonwealth of
Independent States, the Middle
East and South Africa.
FibroGen, Inc. and AstraZeneca are collaborating on the development
and commercialization of roxadustat for the potential treatment of
anemia in the US, China and other
Astellas Pharma Inc., based in Tokyo,
Japan, is a company dedicated to improving the health of
people around the world through the provision of innovative and
reliable pharmaceutical products. For more information, please
FibroGen, Inc., headquartered in
San Francisco, with subsidiary
offices in Beijing and
Shanghai, is a leading
biopharmaceutical company discovering and developing a pipeline of
first-in-class therapeutics. The company applies its
pioneering expertise in HIF, connective tissue growth factor
biology and clinical development to advance innovative medicines
for the treatment of anemia, fibrotic disease and cancer. For more
information, please visit www.fibrogen.com.
Astellas Cautionary Notes
In this press release, statements made with respect to current
plans, estimates, strategies and beliefs, and other statements that
are not historical facts are forward-looking statements about the
future performance of Astellas. These statements are based on
management's current assumptions and beliefs in light of the
information currently available to it and involve known and unknown
risks and uncertainties. A number of factors could cause actual
results to differ materially from those discussed in the
forward-looking statements. Such factors include, but are not
limited to: (i) changes in general economic conditions and in laws
and regulations, relating to pharmaceutical markets, (ii) currency
exchange rate fluctuations, (iii) delays in new product launches,
(iv) the inability of Astellas to market existing and new products
effectively, (v) the inability of Astellas to continue to
effectively research and develop products accepted by customers in
highly competitive markets and (vi) infringements of Astellas'
intellectual property rights by third parties.
Information about pharmaceutical products (including products
currently in development) that is included in this press release is
not intended to constitute an advertisement or medical advice.
FibroGen Forward-Looking Statements
This release contains forward-looking statements regarding
FibroGen's strategy, future plans and prospects, including
statements regarding the development of the company's product
candidates, the potential safety and efficacy profile of our
product candidates, our clinical and regulatory plans and those of
our partners. These forward-looking statements include, but are not
limited to, statements about our plans, objectives, representations
and contentions and are not historical facts and typically are
identified by use of terms such as "may", "will", "should", "on
track", "could", "expect", "plan", "anticipate", "believe",
"estimate", "predict", "potential", "continue" and similar words,
although some forward-looking statements are expressed differently.
Our actual results may differ materially from those indicated in
these forward-looking statements due to risks and uncertainties
related to the continued progress and timing of our various
programs, including the enrollment and results from ongoing and
potential future clinical trials, and other matters that are
described in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2018 and our
quarterly report on 10-Q for the fiscal quarter ended September 30, 2019 filed with the Securities and
Exchange Commission, including the risk factors set forth therein.
Investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
release, and we undertake no obligation to update any
forward-looking statement in this press release, except as required
1 Clinicaltrials.Gov. A Study of Intermittent Oral
Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients
With Anemia NCT02988973. Available
from: https://clinicaltrials.gov/ct2/show/NCT02988973 [Last
accessed: January 2020].
2 Akizawa T, Otsuka T, Yamaguchi Y, et al. A Phase 3,
Multicenter, Randomized, Open-Label, Non-Comparative Study of
Intermittent Oral Roxadustat in ESA-Naive CKD Patients Not on
Dialysis in Japan. Poster session
presented at the Kidney Week Congress, American Society of
Nephrology; November 9, 2019;
Washington, DC, US. Available
[Last accessed: January 2020].
3 Akizawa T, Iwasaki M, Otsuka T, et al. Roxadustat
Treatment of Chronic Kidney Disease-Associated Anemia in Japanese
Patients Not on Dialysis: A Phase 2, Randomized, Double-Blind,
Placebo-Controlled Trial. Adv
4 Ojo A. Addressing the Global Burden of Chronic Kidney
Disease Through Clinical and Translational Research. Trans Am
Clin Climatol Assoc 2014;125:229–246.
5 International Society of Nephrology. Chronic kidney
disease. Global kidney health atlas. Available from:
www.theisn.org/global-atlas [Last accessed: January 2020].
6 Nagata M, Ninomiya T, Doi Y, et al. Trends in the
prevalence of chronic kidney disease and its risk factors in a
general Japanese population: The Hisayama Study. Nephrol Dial
7 Institute for Health Metrics and Evaluation (IHME).
Findings from the Global Burden of Disease Study 2017.
Seattle, WA: IHME, 2018. Available
[Last accessed: January 2020].
8 McClellan W, Aronoff SL, Bolton WK, et al. The
prevalence of anemia in patients with chronic kidney
disease. Curr Med Res
9 Dmitrieva O, de Lusignan S, Macdougall IC, et al.
Association of anaemia in primary care patients with chronic kidney
disease: cross sectional study of quality improvement in chronic
kidney disease (QICKD) trial data. BMC Nephrol
10 Weiner DE, Tighiouart H, Stark PC, et al. Kidney
disease as a risk factor for recurrent cardiovascular disease and
mortality. Am J Kidney Dis 2004;44:198–206.
11Eriksson D, Goldsmith D, Teitsson S, et al.
Cross-sectional survey in CKD patients across Europe describing the association between
quality of life and anaemia. BMC
12Mohanram A, Zhang Z, Shahinfar S, et al. Anemia and
end-stage renal disease in patients with type 2 diabetes and
nephropathy. Kidney Int 2004;66:1131–1138.
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SOURCE Astellas Pharma Inc.