FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, “FibroGen”)
and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji
Yasukawa, Ph.D., “Astellas”) 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 mgEVRENZO® Tablets 50 mgEVRENZO® 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, 2019Renal
anemia in patients not on dialysis: November 27, 2020 |
About Clinical TrialsFor 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 AnemiaCKD 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 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. 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
on May 21, 2020. 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 AstellasAstellas 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 FibroGenFibroGen, 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 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
StatementsThis release contains forward-looking statements
regarding our strategy, future plans and prospects, including
statements regarding the development and commercialization of the
company’s product candidates, the potential safety and efficacy
profile of our product candidates, our clinical programs and
regulatory events, 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, 2019 and our Quarterly
Report on Form 10-Q for quarter ended September 30, 2020 filed with
the Securities and Exchange Commission (SEC), 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
Astellas Pharma Inc.Corporate Advocacy & RelationsTEL:
+81-3-3244-3201 FAX: +81-3-5201-7473
FibroGen, Inc.Investors:Michael Tung, M.D.Corporate Strategy /
Investor RelationsTEL: 1.415.978.1433 | Email:
mtung@fibrogen.com
Media Inquiries:Jennifer
Harrington+1.610.574.9196jennifer.harrington@gcihealth.com
REFERENCES
1 Akizawa T, Iwasaki M, Otsuka T, et al. A Phase 3, Multicenter,
Randomized, Open-label, Active Comparator Conversion Study of
Roxadustat in Non–Dialysis-Dependent (NDD) Patients with Anemia in
Chronic Kidney Disease (CKD). E-poster presented at the American
Society of Nephrology Kidney Week Congress; October 22, 2020;
US.
2 Akizawa T, Yamaguchi Y, Otsuka T, Reusch M. A Phase 3,
Multicenter, Randomized, Two-Arm, Open-Label Study of Intermittent
Oral Dosing of Roxadustat for the Treatment of Anemia in Japanese
Erythropoiesis-Stimulating Agent-Naïve Chronic Kidney Disease
Patients Not on Dialysis. Nephron 2020;144:372–382.
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 Ther 2019;36:1438–1454.
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 Tecklenborg J, Clayton D, Siebert S, and Coley SM. The role of
the immune system in kidney disease. Clin Exp Immunol 2018; 192:
142–150.
6 International Society of Nephrology. Chronic Kidney Disease.
Global Kidney Health Atlas 2017 [online]. Available from:
www.theisn.org/global-atlas [Last accessed: October 2020].
7 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 Transplant
2010;25:2557–2564.
8 Tonelli M, Riella M. Chronic kidney disease and the aging
population. Indian J Nephrol 2014;24:71–74.
9 Institute for Health Metrics and Evaluation (IHME). Findings
from the Global Burden of Disease Study 2017 [online] 2018.
Available from:
http://www.healthdata.org/sites/default/files/files/policy_report/2019/GBD_2017_Booklet.pdf
[Last accessed: October 2020].
10 McClellan W, Aronoff SL, Kline Bolton W, et al. The
prevalence of anemia in patients with chronic kidney
disease. Curr Med Res Opin 2004;20:1501–1510.
11 Akizawa T, Okumura H, Alexandre AF, et al. Burden of Anemia
in Chronic Kidney Disease Patients in Japan: A Literature Review.
Ther Apher Dial 2018;22:444–456.
12 Stauffer ME, Fan T. Prevalence of Anemia in Chronic Kidney
Disease in the United States. PLoS One 2014;9:e84943.
13 Mohanram 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.
14 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.
15 Eriksson 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
Nephrol 2016;17:97.
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