FibroGen, Inc. (NASDAQ:FGEN) today announced that the U.S. Food and
Drug Administration (FDA) has completed its filing review of its
New Drug Application (NDA) for roxadustat for the treatment of
anemia of chronic kidney disease (CKD), in both
non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients.
The application will be considered filed on February 18, 2020. The
FDA has set a Prescription Drug User Fee Act (PDUFA) date of
December 20, 2020.
“The FDA’s acceptance of the roxadustat new drug application is
a critical step towards providing a new treatment option in the
United States for chronic kidney disease patients suffering from
anemia, a serious and often life-threatening disease,” said Enrique
Conterno, Chief Executive Officer, FibroGen.
“There is significant unmet medical need for patients with
anemia of CKD, who have seen only limited advances in the last
three decades,” said Peony Yu, M.D., Chief Medical Officer,
FibroGen. “We intend to work closely with the FDA, in collaboration
with our partner, AstraZeneca, to make this novel oral therapy
available as soon as possible.”
The filing of the roxadustat NDA triggers a $50 million
milestone payment from AstraZeneca (LSE/STO/NYSE: AZN) to
FibroGen.
Roxadustat is the first orally administered small molecule
hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor
accepted by the FDA for review for the treatment of anemia of CKD.
The submission is supported by positive results from a global Phase
3 program encompassing more than 8,000 patients.
Roxadustat is currently approved in China for the treatment of
anemia in patients with CKD, regardless of whether they require
dialysis, and in Japan for the treatment of dialysis patients with
anemia of CKD. FibroGen’s partner Astellas also intends to file a
marketing authorization application with the European Medicines
Agency in the first half of 2020.
About Anemia Associated with CKD
Anemia results from the reduced oxygen-carrying capacity of the
blood, in which patients typically have insufficient red blood
cells and/or low levels of hemoglobin, a protein in red blood cells
that carries oxygen to cells throughout the body. CKD anemia, which
can be associated with increased risk of hospitalization,
cardiovascular complications, and death, also frequently causes
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.
CKD 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. The prevalence of CKD in the adult population is
estimated at 10-12% globally. Anemia is particularly
prevalent in patients with CKD, and life-threatening severe anemia
in CKD patients is often treated with blood transfusions. However,
such transfusions reduce the patient’s opportunity for kidney
transplant, increase risk of infections, and carry 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, as well as improving iron regulation
and overcoming the EPO-suppressive effects of inflammation on
hemoglobin syntheses and red blood cell production.
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/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), and 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. The NDA for roxadustat for treatment of CKD
anemia was submitted to the U.S. FDA in December 2019. 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 the timing, our
strategy, future plans, and prospects regarding the development and
commercialization of the company’s product candidates. These
forward-looking statements include, but are not limited to,
statements about the timing of regulatory events, the potential of
roxadustat to treat CKD anemia patients, receipt of funds from our
collaboration partner, 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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