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 TrialsFor 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 AnemiaCKD 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.15,16 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 AstellasAstellas 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 NotesIn 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.
Contacts for inquiries or additional
information:Astellas Portfolio CommunicationsAnna Otten
TEL: +1 (224) 205-6651 | Email: anna.otten@astellas.com
FibroGen, Inc. Media Inquiries: Sara IacovinoTEL: 1.703.474.4452
| Email: sara.iacovino@gcihealth.com Investors: Michael Tung,
M.D. Corporate Strategy / Investor Relations TEL: 1.415.978.1434 |
Email: mtung@fibrogen.com
REFERENCES
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[Last accessed: April 2020]
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