FibroGen Receives Fast Track Designation From the U.S. FDA for Pamrevlumab for the Treatment of Idiopathic Pulmonary Fibrosis...
September 12 2018 - 9:30AM
FibroGen, Inc. (NASDAQ: FGEN), a biopharmaceutical company, today
announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track designation for the company’s anti-CTGF
antibody, pamrevlumab, for the treatment of patients with
idiopathic pulmonary fibrosis (IPF). This follows review of the
Phase 2 clinical data evaluating pamrevlumab in a
placebo-controlled trial and represents recognition by the FDA that
pamrevlumab has the potential to address an unmet medical need for
this disease.
“This Fast Track designation reflects recognition of the great
need for a new therapeutic to help patients diagnosed with IPF to
reduce the burden and progression of this debilitating disease and
another positive step in developing pamrevlumab for the treatment
of IPF,” said Elias Kouchakji, M.D., Senior Vice President,
Clinical Development and Drug Safety. “We look forward to advancing
pamrevlumab into Phase 3 studies early next year.”
About Fast Track Designation Fast Track
designation is intended to facilitate the development and review of
drugs used to treat serious conditions and to fill an unmet medical
need. Fast Track designation enables the company to have more
frequent interactions with the FDA throughout the drug
development process, so that an approved product can reach the
market expeditiously.
About Idiopathic Pulmonary Fibrosis IPF
is a form of progressive pulmonary fibrosis, or abnormal scarring
of the lungs. As tissue scarring progresses, transfer of oxygen
into the bloodstream is increasingly impaired, leading to
irreversible loss of lung function, as well as high morbidity and
mortality rates. Average life expectancy is estimated to be three
to five years from diagnosis with approximately two-thirds of
patients dying within five years. Survival rates are comparable to
those of some of the deadliest cancers.
Patients with IPF experience debilitating symptoms, including
shortness of breath and difficulty performing routine functions,
such as walking and talking. Other symptoms include chronic dry,
hacking cough, fatigue, weakness, discomfort in the chest, loss of
appetite, and weight loss. Over the last decade, refinements in
diagnosis criteria and enhancements in high-resolution computed
tomography (HRCT) imaging technology have enabled more reliable
diagnosis of IPF without the need for a lung biopsy.
IPF is designated as an orphan disease by the U.S. Food and Drug
Administration, with U.S. prevalence and incidence estimated to be
135,000 cases (defined by ICD-9 code) and 21,000 new cases per
year, respectively, based on Raghu et al. (Am J Respir Crit
Care Med, 2006) and on data from the United Nations Population
Division. We believe the number of patients will continue to grow
due to heightened awareness and improved methods for detection and
diagnosis.
About Pamrevlumab Pamrevlumab is a
first-in-class antibody developed by FibroGen to inhibit the
activity of connective tissue growth factor (CTGF), a common factor
in fibrotic and proliferative disorders characterized by persistent
and excessive scarring that can lead to organ dysfunction and
failure. Pamrevlumab is advancing towards Phase 3 clinical
development for the treatment of idiopathic pulmonary fibrosis
(IPF) and pancreatic cancer and has been granted Orphan Drug
Designation (ODD) in each of these indications, and is currently in
a Phase 2 trial for Duchenne muscular dystrophy (DMD). Pamrevlumab
has received Fast Track designation from the U.S. Food and Drug
Administration for the treatment of patients with locally advanced
unresectable pancreatic cancer. Across all trials, pamrevlumab has
consistently demonstrated a good safety and tolerability profile to
date. For information about pamrevlumab studies currently
recruiting patients, please visit www.clinicaltrials.gov.
About FibroGen FibroGen, Inc., headquartered in
San Francisco, with subsidiary offices in Beijing and Shanghai, 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),
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 candidate, is an oral small molecule
inhibitor of HIF prolyl hydroxylase activity, completing worldwide
Phase 3 clinical development for the treatment of anemia in chronic
kidney disease (CKD), with a New Drug Application (NDA) currently
under review in China by the State Drug Administration (SDA).
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). Pamrevlumab, an
anti-CTGF human monoclonal antibody, is advancing towards 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 our strategy, future
plans and prospects, including statements regarding the development
of the company’s product candidates pamrevlumab and roxadustat, the
potential safety and efficacy profile of our product candidates,
and our clinical, regulatory plans, 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, 2017, and our Quarterly Report on Form 10-Q for
the fiscal quarter ended June 30, 2018 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.
Investor and Media Contact Karen
L. Bergman Vice President, Investor Relations and Corporate
Communications FibroGen, Inc. kbergman@fibrogen.com (415)
978-1433
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