FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S.
Food and Drug Administration (FDA) has issued a complete response
letter regarding the New Drug Application (NDA) for roxadustat for
the treatment of anemia of chronic kidney disease (CKD).
The letter indicates the FDA will not approve the roxadustat NDA
in its present form and has requested additional clinical study of
roxadustat be conducted, prior to resubmission.
“We are deeply disappointed with this result, and this is an
unfortunate day for patients suffering from anemia of CKD in the
United States,” said Enrique Conterno, Chief Executive Officer,
FibroGen. “Roxadustat is changing the lives of patients around the
world, and we and our partner AstraZeneca will discuss next steps
in the U.S.”
Roxadustat is approved in China, Japan, Chile, and South Korea
for the treatment of anemia of CKD in both non-dialysis-dependent
(NDD) and dialysis-dependent (DD) adult patients and has received a
positive opinion from the Committee for Medicinal Products for
Human Use (CHMP), the European Medicines Agency’s committee
responsible for human medicines. The European Commission decision
is expected by the end of August.
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 percent 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
percent 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 RoxadustatRoxadustat, 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, Chile, and South Korea
for the treatment of anemia of CKD in adult patients on dialysis
(DD) and not on dialysis (NDD). In Europe, the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has adopted a positive opinion relating to the use of
roxadustat for the treatment of adult patients with symptomatic
anemia associated with chronic kidney disease (CKD). 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 of CKD 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 of CKD 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 of 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 and product,
the potential safety and efficacy profile of our product candidates
and product, our clinical programs and regulatory events, and those
of our partners, and the commercial and clinical success of
HIFRENZO (roxadustat) in anemia of CKD. 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 June 30, 2021 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 Relations+1.415.978.1434mtung@fibrogen.com
Media:GCI HealthFibroGenMedia@gcihealth.com
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