TOKYO and SAN FRANCISCO, Sept.
20, 2019 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503,
President and CEO: Kenji Yasukawa,
Ph.D., "Astellas") and FibroGen, Inc. (Nasdaq: FGEN, Interim CEO:
James A Schoeneck., "FibroGen") today announced that Japan's Ministry of Health, Labour and Welfare
(MHLW) approved Evrenzo® (generic name: roxadustat) for
the treatment of anemia associated with chronic kidney disease
(CKD) in dialysis patients.
Roxadustat is a first-in-class orally administered inhibitor of
hypoxia-inducible factor (HIF) prolyl hydroxylase that corrects
anemia by a mechanism of action that is different from that of
erythropoiesis-stimulating agents (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.
"Evrenzo® is a valuable new treatment option for
dialysis patients with CKD anemia," said Bernhardt G. Zeiher, M.D., Chief Medical
Officer, Astellas. "Astellas is committed to improving the health
of people worldwide and expanding treatment options, especially
within the dialysis community where there is high-unmet need. We
are delighted to bring this important new treatment option to both
patients suffering from, and healthcare professionals treating,
this debilitating condition."
CKD anemia can severely worsen the outcomes of kidney disease,
increasing the rate of progression to renal failure1 and
the likelihood of cardiovascular complications.2 It also
significantly reduces patients' quality of life and their cognitive
ability.3 Reaching and maintaining target hemoglobin
levels can present challenges and roxadustat provides an
alternative therapeutic option.
"We appreciate the commitment and focus of our partner Astellas
as we work together to bring a new therapy to CKD anemia patients
on dialysis in Japan," said K.
Peony Yu, M.D., Chief Medical Officer, FibroGen. "With this
approval in Japan, NDA approval in
China, and EU MAA and US NDA
preparations underway, we are another step closer to our goal of
addressing the significant unmet medical need of patients living
with anemia of CKD, worldwide."
The approval is based on four Phase 3 studies conducted in CKD
anemia patients on dialysis in Japan.4,5,6,7 The studies
demonstrated that roxadustat was effective at raising hemoglobin
and that it was well-tolerated. This marks the first approval for
roxadustat through the Astellas and FibroGen
collaboration.
|
Product
Information
|
|
PRODUCT
NAME
|
Evrenzo® Tablets 20mg
Evrenzo® Tablets 50mg
Evrenzo®
Tablets 100mg
|
GENERAL
NAME
|
Roxadustat
|
INDICATIONS
|
Renal anemia in
patients on dialysis
|
DOSAGE AND
ADMINISTRATION
|
Patients not on
erythropoiesis-stimulating agent treatment.
For adults, the usual
dosage is 50mg, 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 3.0mg/kg.
Patients switching
from erythropoiesis-stimulating agents.
For adults, the usual
dosage is 70 or 100mg, 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 3.0mg/kg.
|
APPROVAL
DATE
|
September 20,
2019
|
About Chronic Kidney Disease (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.8 Worldwide, more than 1 in 10 people
are living with CKD.9 In Japan, specifically, the prevalence of CKD has
increased significantly over time.10 Although CKD can
occur at any age, it becomes more common in aging populations, and
the prevalence is increasing. CKD is a critical worldwide
healthcare issue that represents a large and growing unmet medical
need.
Anemia is a common early complication of CKD11,
affecting approximately 20% of patients with CKD.12 It
results from the failing kidneys' diminished ability to produce
erythropoietin that stimulates red blood cell production from the
bone marrow, and is associated with significant morbidity and
mortality in dialysis and non-dialysis populations, increasing in
both prevalence and severity as kidney disease
worsens.13 CKD anemia increases the risk of adverse
cardiovascular events, worsens renal outcomes and negatively
impacts patients' quality of life.14,15 In addition, CKD
can be both a cause and a consequence of cardiovascular disease and
is now a critical worldwide healthcare issue that represents a
large and growing unmet medical need.
About Roxadustat
In addition to receiving approval from the Pharmaceuticals and
Medical Devices Agency (PMDA) in Japan, roxadustat is approved for treatment of
anemia associated with CKD in China in both dialysis-dependent and
non-dialysis-dependent CKD patients. U.S. NDA and EU MAA
preparation is underway. Roxadustat is also in Phase
3 clinical development in the U.S. and Europe and in Phase 2/3 development
in China for anemia associated
with myelodysplastic syndromes. For information
about roxadustat studies, please visit clinicaltrials.gov at:
https://clinicaltrials.gov/ct2/results?term=roxadustat&Search=Search.
Astellas and FibroGen 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 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.
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 and developing a pipeline of first-in-class
therapeutics. The company applies its pioneering expertise in
hypoxia-inducible factor (HIF), connective tissue growth factor
(CTGF) 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) which 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 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,
and 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 June 30, 2019 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.
References:
1 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 Sep;66(3):1131-8.
2 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 Aug;44(2):198-206.
3 Eriksson D et al. Cross-sectional survey in CKD
patients across Europe describing
the association between quality of life and anaemia. BMC
Nephrology. 2016;17:97.
4 1517-CL-0302: Announced on a press release issued
on October 31, 2017. Available at:
https://www.astellas.com/jp/en/news?type=date&tab=date&year=2017&month=10
5 1517-CL-0308: Announced on slide no. 29 of
presentation material at Astellas FY2017 business
announcement on April 26, 2018.
Available at:
https://sw4503.swcms.net/en/ir-library/business-results/inframe/main/00/teaserItems1/00/linkList/02/link/4q2018_pre_en.pdf
6 1517-CL-0312: Announced on slide no. 29 of
presentation material at Astellas FY2017 business
announcement on April 26, 2018.
Available at:
https://sw4503.swcms.net/en/ir-library/business-results/inframe/main/00/teaserItems1/00/linkList/02/link/4q2018_pre_en.pdf
7 1517-CL-0307: Announced on a press release issued
on May 31. Available at:
https://www.astellas.com/jp/en/news/11951
8 Ojo, A. Addressing the Global Burden of Chronic
Kidney Disease Through Clinical and Translational Research.
Transactions of the American Clinical and Climatological
Association. 2014, No. 125, p. 229-246.
9 The Global Kidney Health Atlas. International
Society of Nephrology (ISN). Available at:
https://www.kidneycareuk.org/news-and-campaigns/news/estimated-1-10-people-worldwide-have-chronic-kidney-disease/.
Last accessed August 2019.
10 Nagata M, Ninomiya T, Doi Y, Yonemoto K, Kubo M,
Hata J, Tsuruya K, Iida M, Kiyohara Y. Nephrol Dial
Transplant. 2010, Aug, vol. 25, no.8, 2557-2564.
11 McClellan W, Aronoff SL, Bolton WK, et al. The
prevalence of anemia in patients with chronic kidney
disease. Curr.Med.Res.Opin. 2004;20:1501–1510.
12 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 Nephrology.
2013:25;14:24.
13 KDOQINational Kidney Foundation: KDOQI Clinical
Practice Guidelines and Clinical Practice Recommendations for
Anemia in Chronic Kidney Disease. Am J Kidney Dis 47 [Suppl 3]:
S11–S145, 2006.
14 Eriksson D et al. Cross-sectional survey in CKD
patients across Europe describing
the association between quality of life and anaemia. BMC
Nephrology. 2016;17:97.
15 KDOQINational Kidney Foundation: KDOQI Clinical
Practice Guidelines and Clinical Practice Recommendations for
Anemia in Chronic Kidney Disease. Am J Kidney Dis 47 [Suppl 3]:
S11–S145, 2006.
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