TOKYO, Nov. 27, 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 that Japan's Ministry of Health, Labour and Welfare
(MHLW) approved EVRENZO® (roxadustat) for the treatment
of anemia of chronic kidney disease (CKD) in adult patients not on
dialysis. This marks the second approval in Japan for roxadustat through the Astellas and
FibroGen collaboration, after the therapy was approved and launched
for use in adult patients with anemia of CKD on dialysis last
year.
"We are delighted roxadustat is now approved in Japan for adults with anemia of CKD not on
dialysis, as it allows even more patients to access this important
new treatment option," said Bernhardt G.
Zeiher, M.D., Chief Medical Officer, Astellas. "With its
novel mechanism of action and oral administration, we hope
roxadustat will alleviate some of the burden associated with anemia
of CKD prior to the initiation of dialysis and deliver meaningful
improvements in the lives of these patients."
This approval is based on results obtained from three clinical
studies in more than 500 Japanese patients with anemia of CKD not
on dialysis. The first, an open-label Phase 3 conversion study
versus active comparator, darbepoetin alfa, met the primary
efficacy endpoint of non-inferiority and continued to demonstrate
maintenance of hemoglobin (Hb) levels over time.1
Roxadustat was generally well tolerated, and the safety profile was
comparable with that of darbepoetin alfa.1 The
other two studies (one Phase 3 and one Phase 2) support the safety
and efficacy of roxadustat in erythropoiesis-stimulating agent
(ESA)-untreated patients.2,3
"Today's approval is another milestone achievement for both
FibroGen and Astellas," said K. Peony Yu, M.D., Chief Medical
Officer, FibroGen. "By bringing roxadustat to adult patients living
with anemia of CKD, both on dialysis and not on dialysis, we are
continuing our efforts to meet the significant unmet medical need
of patients in this community."
The approval of the supplementary New Drug Application (sNDA)
for roxadustat in Japan for the
treatment of anemia of CKD in adult patients not on dialysis
triggers a milestone payment of $15
million by Astellas to FibroGen.
As a first-in-class orally administered inhibitor of
hypoxia-inducible factor (HIF) prolyl hydroxylase (PH), roxadustat
increases Hb levels through a mechanism of action that is different
from that of traditional ESAs. As a HIF-PH inhibitor, roxadustat
activates the body's natural protective response to reduced oxygen
levels in the blood. This response involves the regulation of
multiple, coordinated processes that lead to the correction of
anemia.
Product Information
PRODUCT
NAME
|
EVRENZO®
Tablets 20 mg
EVRENZO®
Tablets 50 mg
EVRENZO®
Tablets 100 mg
|
GENERAL
NAME
|
Roxadustat
|
INDICATIONS
|
Renal
anemia
|
DOSAGE AND
ADMINISTRATION
|
Patients not on
erythropoiesis-stimulating agent treatment.
For adults, the usual
dosage is 50 mg, the starting dose, as roxadustat orally
administered three times weekly. The dosage thereafter should be
adjusted according to the patient's condition; however, the maximum
dose should not exceed 3.0 mg/kg.
Patients switching
from erythropoiesis-stimulating agents.
For adults, the usual
dosage is 70 or 100 mg, the starting dose, as
roxadustat orally
administered three times weekly. The dosage thereafter
should be adjusted
according to the patient's condition; however, the
maximum dose should
not exceed 3.0 mg/kg.
|
APPROVAL
DATES
|
Renal anemia in
patients on dialysis: September 20, 2019
Renal anemia in
patients not on dialysis: November 27, 2020
|
About Clinical Trials
For more information about the
clinical trials associated with this approval (1517-CL-0310,
1517-CL-0314, 1517-CL-0303), please visit
www.clinicaltrials.gov.
About CKD and Anemia
CKD is characterized by a
progressive loss of kidney function caused by damage to the kidneys
resulting from conditions such as hypertension, diabetes or
immune-regulated inflammatory conditions.4,5 Worldwide,
1 in 10 people are living with CKD.6 In Japan specifically, the prevalence of CKD has
increased significantly over time.7 Although CKD can
occur at any age, it becomes more common in aging populations and
the prevalence is increasing.8 In addition, CKD is
predicted to become the fifth most common cause of premature death
by 2040 globally.9 It is a critical worldwide healthcare
issue that represents a large and growing unmet medical need.
Anemia is a common complication of CKD,10 resulting
from the failing kidneys' ability to produce erythropoietin,
reduced oxygen sensing, and increased hepcidin and iron deficiency
resulting from chronic inflammation. Anemia affects approximately
one-third of Japanese patients with Stage 3–5 CKD.11 It
is associated with significant morbidity and mortality in dialysis
and non-dialysis populations, increasing in both prevalence and
severity as kidney disease worsens.12 Anemia of CKD
increases the risk of adverse cardiovascular events, worsens renal
outcomes and can negatively impact patients' quality of
life.13-15
About Roxadustat
Roxadustat is a first-in-class
orally administered inhibitor of HIF-PH, which increases hemoglobin
levels through a mechanism of action that is different from that of
traditional ESAs. As a HIF-PH inhibitor, roxadustat activates a
response that occurs naturally when the body responds to reduced
oxygen levels in the blood. Roxadustat promotes red blood cell
production through increased endogenous production of
erythropoietin; improved iron absorption, transport and
mobilization; and downregulation of hepcidin, which helps to
overcome the negative impact of inflammation on hemoglobin
synthesis and red blood cell production.
Roxadustat is approved and launched for the treatment of anemia
of CKD in Japan and China in adult patients on dialysis (DD) and
not on dialysis (NDD). A New Drug Application for the treatment of
anemia of CKD in patients both DD and NDD is under review by the
U.S. Food and Drug Administration with a decision expected in
December 2020. The marketing
authorisation application for roxadustat for the treatment of
anemia of CKD in patients both DD and NDD was accepted by the
European Medicines Agency for review. Several other licensing
applications for roxadustat have been submitted by Astellas and
AstraZeneca to regulatory authorities across the globe, which are
currently in review.
Astellas and FibroGen are collaborating on the development and
commercialization of roxadustat for the potential treatment of
anemia in territories including Japan, Europe, Turkey, Russia and 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 U.S., China and
other markets in the Americas and in Australia/New
Zealand as well as Southeast
Asia.
About Astellas
Astellas Pharma Inc., is a
pharmaceutical company conducting business in more than 70
countries around the world. We are promoting the Focus Area
Approach that is designed to identify opportunities for the
continuous creation of new drugs to address diseases with high
unmet medical needs by focusing on Biology and Modality.
Furthermore, we are also looking beyond our foundational Rx focus
to create Rx+® healthcare solutions that combine our
expertise and knowledge with cutting-edge technology in different
fields of external partners. Through these efforts, Astellas stands
on the forefront of healthcare change to turn innovative science
into value for patients. For more information, please visit our
website at https://www.astellas.com/en.
About FibroGen
FibroGen, Inc. is a biopharmaceutical
company committed to discovering, developing and commercializing a
pipeline of first-in-class therapeutics. The company applies its
pioneering expertise in hypoxia-inducible factor (HIF) and
connective tissue growth factor (CTGF) biology to advance
innovative medicines for the treatment of unmet needs. The Company
is currently developing and commercializing roxadustat, an oral
small molecule inhibitor of HIF prolyl hydroxylase activity, for
anemia associated with chronic kidney disease (CKD). Roxadustat is
also in clinical development for anemia associated with
myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia
(CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in
clinical development for the treatment of idiopathic pulmonary
fibrosis (IPF), locally advanced unresectable pancreatic cancer
(LAPC), Duchenne muscular dystrophy (DMD), and coronavirus
(COVID-19). 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 the commercial plans 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 clinical, regulatory and commercial operations and
results, 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 June
30, 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.
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|
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(NDD) Patients with Anemia in Chronic Kidney Disease (CKD).
E-poster presented at the American Society of Nephrology Kidney
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