FibroGen, Inc. (NASDAQ:FGEN), today announced the submission of a
New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for roxadustat for the treatment of anemia of chronic kidney
disease (CKD), in both non-dialysis-dependent (NDD) and
dialysis-dependent (DD) CKD patients.
Roxadustat is the first orally administered small molecule
hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor
submitted for FDA regulatory approval for the treatment of anemia
of CKD. Regulatory approval of roxadustat is supported by positive
results from a global Phase 3 program encompassing 15 trials that
enrolled more than 10,000 patients, worldwide.
“The submission of this NDA is a major step toward our goal of
bringing this novel oral medicine to U.S. patients suffering from
anemia in CKD,” said Jim Schoeneck, Interim Chief Executive
Officer, FibroGen. “We, in collaboration with our partner
AstraZeneca, look forward to working with the FDA during the NDA
review, and to the potential of roxadustat as a new therapeutic
option for treating CKD anemia, in patients on dialysis and not on
dialysis.”
About Anemia Associated with CKD Anemia can be
a serious medical condition in which patients have insufficient red
blood cells and low levels of hemoglobin, a protein in red blood
cells that carries oxygen to cells throughout the body. Anemia in
CKD is associated with increased risk of hospitalization,
cardiovascular complications and death, also frequently causing
significant fatigue, cognitive dysfunction and reduced quality of
life. Severe anemia is common in patients with CKD, cancer,
myelodysplastic syndromes (MDS), inflammatory diseases, and other
serious illnesses.
Anemia is particularly prevalent in patients with CKD. The
prevalence of CKD in the adult population is estimated at 10-12%
globally and is generally a progressive disease characterized by
gradual loss of kidney function that may eventually lead to kidney
failure, or end stage renal disease, requiring dialysis or kidney
transplant to survive. Blood transfusion is used for treating
life-threatening severe anemia. However, blood transfusions reduce
the patient’s opportunity for kidney transplant, increase risk of
infections and the risk of complications such as heart failure and
allergic reactions.
According to the United States Renal Data System (USRDS), over
14% of the U.S. adult population is affected by CKD, and a majority
of dialysis-eligible CKD patients are currently on dialysis. It is
estimated that approximately 509,000 patients are receiving
dialysis in the U.S. as of 2016.
About Roxadustat Roxadustat (FG-4592) is a
first-in-class, orally administered small molecule HIF-PH inhibitor
that promotes erythropoiesis through increasing endogenous
production of erythropoietin, improving iron regulation, and
overcoming the negative impact of inflammation on hemoglobin
syntheses and red blood cell production by downregulating hepcidin.
Administration of roxadustat has been shown to induce coordinated
erythropoiesis, increasing red blood cell count while maintaining
plasma erythropoietin levels within or near normal physiologic
range in multiple subpopulations of chronic kidney disease (CKD)
patients, including in the presence of inflammation and without a
need for supplemental intravenous iron. Roxadustat is currently
approved in China for the treatment of anemia in CKD patients on
dialysis and patients not on dialysis and approved in Japan for the
treatment of anemia in CKD patients on dialysis. Roxadustat is 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 (MDS), and in a Phase 2 U.S. trial for treatment of
chemotherapy-induced anemia.
Astellas and FibroGen are collaborating on the development and
commercialization of roxadustat for the treatment of anemia in
territories including Japan, Europe, the Commonwealth of
Independent States, the Middle East, and South Africa. AstraZeneca
and FibroGen are collaborating on the development and
commercialization of roxadustat for the treatment of anemia in the
U.S., China, and other markets in the Americas, and in Australia
and New Zealand, as well as Southeast Asia.
About FibroGen FibroGen, Inc., headquartered in
San Francisco, California, with subsidiary offices in Beijing and
Shanghai, People’s Republic of China, 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) and connective tissue
growth factor (CTGF) biology, and clinical development to advance
innovative medicines for the treatment of anemia, fibrotic disease,
and cancer. Roxadustat, the company’s most advanced product, is an
oral small molecule inhibitor of HIF prolyl hydroxylase (HIF-PH)
activity, completing worldwide Phase 3 clinical development for the
treatment of anemia in chronic kidney disease (CKD), is approved by
the National Medical Products Administration (NMPA) in China for
CKD patients on dialysis and not on dialysis and by the Ministry of
Health, Labour and Welfare (MHLW) in Japan for CKD patients on
dialysis. Roxadustat is 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 (MDS), and in a Phase 2
U.S. trial for treatment of chemotherapy-induced anemia.
Pamrevlumab, an anti-CTGF human monoclonal antibody, is in Phase 3
clinical development for the treatment of idiopathic pulmonary
fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2
trial for Duchenne muscular dystrophy (DMD). FibroGen is also
developing a biosynthetic cornea in China. For more information,
please visit www.fibrogen.com.
Forward-Looking Statements This release
contains forward-looking statements regarding our strategy, future
plans and prospects, including statements regarding the development
of the company’s product candidates, the potential safety and
efficacy profile of roxadustat, the potential for our Phase 3
program data to form the basis of a regulatory approval, 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 September 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.
Contact:FibroGen, Inc.
Media Inquiries: Sara Iacovino
1.703.474.4452sara.iacovino@gcihealth.com
Investors: Michael Tung, M.D.Investor
Relations1.415.978.1433ir@fibrogen.com
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