FibroGen, Inc. (Nasdaq: FGEN) and its partner, AstraZeneca
(LSE/STO/Nasdaq: AZN), today announced that the Cardiovascular and
Renal Drugs Advisory Committee of the U.S. Food and Drug
Administration (FDA) will hold an advisory committee (AdCom)
meeting to review the new drug application for roxadustat in the
U.S. The companies have not received a confirmed AdCom meeting date
from the FDA.
“While disappointed with the news today, FibroGen and
AstraZeneca are committed to working with the FDA to bring
roxadustat to patients with anemia of CKD in the U.S. as soon as
possible,” said Enrique Conterno, Chief Executive Officer,
FibroGen. “We continue to be confident in the efficacy and safety
profile of this potential new medicine based on positive results
from a global Phase 3 program encompassing more than 8,000
patients.”
Roxadustat has been approved in China, Japan and Chile for the
treatment of anemia of CKD in both non-dialysis dependent (NDD) and
dialysis-dependent (DD) adult patients.
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.
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, HIF-PH inhibitors that
promote erythropoiesis, or red blood cell 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 myelodysplastic syndromes (MDS) and for chemotherapy-induced
anemia (CIA).
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 with
chronic kidney disease (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, and 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, in Australia/New Zealand, and 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 locally advanced
unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy
(DMD), and idiopathic pulmonary fibrosis (IPF). 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 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, 2020 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.Corporate Strategy
/ Investor Relations1.415.978.1434mtung@fibrogen.com
Media:Jennifer
Harrington+1.610.574.9196Jennifer.Harrington@gcihealth.com
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