FibroGen Announces FDA Advisory Committee to Review Roxadustat New Drug Application Tentatively Scheduled for July 15, 2021
April 06 2021 - 7:50PM
FibroGen, Inc. (NASDAQ: FGEN) announced that the U.S. Food and
Drug Administration (FDA) has informed the Company late today it
has tentatively scheduled a Cardiovascular and Renal Drug Advisory
Committee (CRDAC) on July 15, 2021 to review the New Drug
Application (NDA) for roxadustat for the treatment of anemia of
chronic kidney disease (CKD) in both dialysis-dependent and
non-dialysis-dependent patients.
The NDA submission was supported by positive results from a
global Phase 3 program encompassing more than 8,000 patients.
Roxadustat is approved and launched in China and Japan for the
treatment of anemia of CKD in patients on dialysis and not on
dialysis.
About Cardiovascular and Renal Drugs Advisory
Committee The Cardiovascular and Renal Drugs Advisory
Committee (CRDAC) reviews and evaluates available data concerning
the safety and effectiveness of marketed and investigational drug
products for use in the treatment of cardiovascular and renal
disorders, and makes appropriate recommendations to the
Commissioner of Food and Drugs. Although the FDA will consider the
recommendation of the panel, the final decision regarding the
approval of a product is made solely by the FDA.
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 of CKD in
patients both on dialysis and not on dialysis was filed by our
partner Astellas and accepted by the European Medicines Agency for
review on 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 FibroGen
FibroGen, 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 Statements
This release contains forward-looking statements regarding the
Company’s prospects, including statements regarding the safety and
efficacy profile of our product candidates and regulatory results,
strategy and interactions, including those of our partners.
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 filed with the Securities and Exchange
Commission (SEC), and the risk factors set forth therein, including
without limitation, risks related to obtaining regulatory approval
and the planned FDA Advisory Committee meeting. 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
Harrington1.610.574.9196Jennifer.Harrington@gcihealth.com
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