FibroGen, Inc. (Nasdaq: FGEN) today announced that the U.S.
Food and Drug Administration (FDA) has extended the review period
of the New Drug Application (NDA) for roxadustat for the treatment
of anemia of chronic kidney disease (CKD) by three months. The
updated Prescription Drug User Fee Act (PDUFA) action date is March
20, 2021.
The FDA is close to finalizing its review of the NDA and
FibroGen is submitting additional analyses of existing roxadustat
clinical data, which require an extension of the original PDUFA
date.
“FibroGen is working closely with the FDA, in collaboration with
our partner, AstraZeneca, to support the final review of the new
drug application for roxadustat,” said Enrique Conterno, Chief
Executive Officer, FibroGen. “There is significant unmet
medical need for the treatment of anemia of CKD, and we are
committed to bringing roxadustat to patients in the U.S. as soon as
possible.”
Roxadustat, an oral small molecule hypoxia-inducible factor
prolyl hydroxylase (HIF-PH) inhibitor, is the first HIF-PH
inhibitor accepted by the FDA for review for the
treatment of anemia of CKD. The NDA for roxadustat is based on
positive results from a global Phase 3 program encompassing more
than 8,000 patients.
About Anemia of CKDChronic kidney disease (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. CKD
is estimated to occur in approximately 10-12% of adults worldwide
and is predicted to become the fifth most common cause of premature
death globally by 2040.
Anemia, a serious medical condition in which patients have
insufficient red blood cells and low levels of hemoglobin, is a
common early complication of CKD, affecting approximately 20% of
CKD patients. Anemia of CKD is associated with an increased risk of
hospitalization, cardiovascular complications, and death, and can
also cause significant fatigue, cognitive dysfunction and reduced
quality of life. Blood transfusions are used for treating severe
anemia, however, they may reduce a patient’s opportunity for kidney
transplant and can increase the risk of infection and/or
complications such as heart failure and allergic reactions.
About Roxadustat Roxadustat, an oral medicine,
is the first in a new class of medicines called HIF-PH inhibitors
that promotes erythropoiesis, or RBC production, through increased
endogenous production of erythropoietin; improved iron absorption
and mobilization; and downregulation of hepcidin. Roxadustat is
also in clinical development for anemia associated with MDS
syndromes and for chemotherapy-induced anemia.
Roxadustat is approved in China, Japan, and Chile for the
treatment of anemia of CKD in adult patients on dialysis (DD) and
not on dialysis (NDD). In Europe, the Marketing Authorization
Application for roxadustat for the treatment of anemia in CKD in
NDD and DD patients was filed by Astellas Pharma Inc. (Astellas)
and accepted by the European Medicines Agency for review in May
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, other markets in the
Americas and in Australia/New Zealand as well as Southeast
Asia.
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.
Forward-Looking StatementsThis release contains
forward-looking statements regarding our strategy, future plans and
prospects, including statements regarding development and
commercialization of the Company’s product candidates, including
roxadustat regulatory events. 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:FibroGen, Inc.
Investors:Michael Tung, M.D.Investor
Relations+1.415.978.1434mtung@fibrogen.com
Media:Jennifer
Harrington+1.610.574.9196Jennifer.Harrington@gcihealth.com
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