TOKYO and SAN FRANCISCO, May 20,
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 marketing authorization application (MAA) for
roxadustat for the treatment of anemia in adult patients with
chronic kidney disease (CKD) has been accepted by the European
Medicines Agency (EMA) for regulatory review.
The MAA is supported by positive results from a pivotal Phase 3
program, which involved more than 9,000 patients
worldwide.1-7 The MAA dossier includes the DOLOMITES
study, the results of which will be disclosed later this
year.8,9 Results from these studies support roxadustat
as efficacious in increasing and maintaining target hemoglobin
levels with reduced use of intravenous iron in adult patients with
CKD anemia, both those who are dialysis dependent (DD) and those
non-dialysis dependent (NDD). These data also support a favorable
risk:benefit profile with cardiovascular (CV) and general safety of
roxadustat reflective of the underlying conditions of the CKD
population.1-6
"This acceptance marks a significant milestone for roxadustat,
which we believe has the potential to offer an important new oral
therapeutic option in the EU for the management of anemia in adults
with chronic kidney disease," said Bernhardt G. Zeiher, M.D., Chief Medical
Officer, Astellas. "Chronic kidney disease impacts one in eight
people in Europe, of whom one in
five are affected by anemia that is often untreated or not treated
to target. We look forward to the review and assessment by EMA in
the hope of bringing this innovative treatment to patients across
the EU."
"There is significant unmet medical need for patients with
anemia of CKD, a serious and often life-threatening disease," said
K. Peony Yu, M.D., Chief Medical Officer, FibroGen. "This
submission and FibroGen's recent submission of a New Drug
Application in the U.S. are supported by positive results from the
largest global phase 3 program in patients with CKD anemia. We look
forward to working with Astellas during the EMA's review of the
MAA, and to the potential of roxadustat as a new therapeutic option
for treating anemia in CKD patients on dialysis and not on dialysis
across Europe."
EMA's acceptance of the roxadustat MAA for treatment of anemia
in adult patients with CKD on dialysis and not on dialysis triggers
a milestone payment of $130 million
by Astellas to FibroGen.
About Clinical Trials
For more information
about the clinical trials associated with the accepted MAA
(1517-CL-0613 (PYRENEES),1 1517-CL-0608
(ALPS),2 FGCL-4592-060
(ANDES),3 FGCL-4592-063
(HIMALAYAS),4 FGCL-4592-064
(SIERRAS),5 D5740C00001
(OLYMPUS),6 D5740C00002
(ROCKIES),7 1517-CL-0610
(DOLOMITES)8,9), please visit
www.clinicaltrials.gov or clinicaltrialsregister.eu.
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.10 Worldwide 1 in 10 people are
living with CKD.11 In Europe 1 in 8 people are living with
CKD,11 of whom 1 in 5 are affected by anemia, this
rises to 1 in 2 in people with the most severe CKD (CKD stage
5).12 CKD is predicted to become the fifth most common
cause of premature death globally by 2040.13 It is a
critical worldwide healthcare issue that represents a large and
growing unmet medical need.
Anemia is a common complication of CKD,14 resulting
from the failing kidneys' diminished ability to produce
erythropoietin, which stimulates red blood cell production in 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.15 Anemia associated with CKD increases the risk
of adverse cardiovascular events, worsens renal outcomes and can
negatively impact patients' quality of life.16–18
About Roxadustat
Roxadustat is a
first-in-class orally administered inhibitor of hypoxia-inducible
factor (HIF) prolyl hydroxylase (PH), which increases hemoglobin
levels with a mechanism of action that is different from that of
erythropoiesis-stimulating agents. As a HIF-PH inhibitor,
roxadustat activates a response that occurs naturally when the body
responds to reduced oxygen levels in the blood. This response
involves the regulation of multiple, complementary processes to
promote erythropoiesis and to 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. A supplemental New Drug Application (sNDA) has
been submitted to Japan's
Pharmaceuticals and Medical Devices Agency for NDD patients and a
New Drug Application (NDA) has been submitted in the US in both DD
and NDD patients.
Astellas and FibroGen are collaborating on the development and
commercialization 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 and
AstraZeneca are collaborating on the development and
commercialization of roxadustat for the potential treatment of
anemia in the US, China and other
markets in the Americas and in Australia/New
Zealand as well as Southeast
Asia.
About Astellas
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
visit https://www.astellas.com/en.
About FibroGen
FibroGen, Inc., headquartered in San
Francisco, with subsidiary offices in Beijing and Shanghai, is a leading biopharmaceutical
company discovering, developing, and commercializing a pipeline of
first-in-class therapeutics. The company applies its
pioneering expertise in hypoxia-inducible factor, 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
that ended December 31, 2019 and our
quarterly report on 10-Q for the fiscal quarter that ended
March 31, 2020 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
by law.
REFERENCES
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SOURCE Astellas Pharma US, Inc.