FibroGen Receives Fast Track Designation from the U.S. FDA for Pamrevlumab for the Treatment of Duchenne Muscular Dystrophy
April 12 2021 - 7:00AM
FibroGen, Inc. (NASDAQ: FGEN) 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 Duchenne muscular dystrophy (DMD). This designation
follows review of the Phase 2 clinical data from a single-arm trial
in non-ambulatory patients with DMD, and represents recognition by
the FDA that pamrevlumab has the potential to address an unmet
medical need for this disease. Pamrevlumab is currently being
evaluated in two Phase 3 trials for the treatment of DMD.
“Fast Track designation by the FDA for pamrevlumab in DMD
underscores the high unmet medical need for patients suffering from
this debilitating disease and potential to advance a new treatment
option,” said Mark Eisner, M.D, M.P.H, Chief Medical Officer,
FibroGen. “We look forward to working closely with the FDA on the
development of pamrevlumab as a potential therapy for DMD.”
About Fast Track DesignationFast 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 Duchenne Muscular Dystrophy Duchenne
muscular dystrophy (DMD) is a rare and debilitating neuromuscular
disease that affects approximately 1 in every 5,000 newborn boys.
About 20,000 children are diagnosed with DMD globally each year.
The fatal disease is caused by a genetic mutation leading to the
absence or defect of dystrophin, a protein necessary for normal
muscle function. The absence of dystrophin results in muscle
weakness, muscle loss, fibrosis, and inflammation. Patients with
DMD are often wheelchair-bound before the age of 12, and their
progressive muscle weakness may lead to serious medical problems
relating to respiratory and cardiac muscle.
About PamrevlumabPamrevlumab is a
first-in-class antibody developed by FibroGen that inhibits the
activity of connective tissue growth factor (CTGF), an important
biological mediator in fibrotic and proliferative disorders.
Pamrevlumab is in Phase 3 clinical development for the treatment of
locally advanced unresectable pancreatic cancer (LAPC), Duchenne
muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF).
For information about pamrevlumab studies currently recruiting
patients, please visit www.clinicaltrials.gov.
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 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. 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 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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