FibroGen, Inc. (Nasdaq: FGEN) (the “Company”) today provided
clarification of certain prior disclosures of U.S. primary
cardiovascular safety analyses from the roxadustat Phase 3 program
for the treatment of anemia of chronic kidney disease (“CKD”).
“As members of senior management were preparing for the upcoming
FDA Advisory Committee meeting, we became aware that the primary
cardiovascular safety analyses included post-hoc changes to the
stratification factors,” said Enrique Conterno, Chief Executive
Officer, FibroGen. “While all of the analyses set forth below,
including the differences in the stratification factors, were
included in the NDA, we promptly decided to clarify this issue with
the FDA and communicate with the scientific and investment
communities.”
Mr. Conterno continued, “It is important to emphasize that this
does not impact our conclusion regarding the comparability, with
respect to cardiovascular safety, of roxadustat to epoetin-alfa in
dialysis-dependent (DD) patients and to placebo in non-dialysis
dependent (NDD) patients. We continue to have confidence in
roxadustat’s benefit risk profile.”
FibroGen continues to prepare for the FDA Advisory Committee
meeting and will work closely with the FDA to bring this important
new treatment to patients living with anemia of CKD.
There is no change in the underlying roxadustat data, or to the
efficacy analyses from the Phase 3 program. The Company has begun a
comprehensive internal review to ensure such issues do not occur in
the future.
Pooled Cardiovascular Safety DataAs previously
disclosed, the Company agreed with the FDA in the pre-NDA meeting
that the primary analysis in non-dialysis would be ITT (intention
to treat with long-term follow up) and in dialysis would be OT-7
(on-treatment plus 7 days). MACE, a composite endpoint of all-cause
mortality, stroke, and myocardial infarction, was the primary
safety endpoint agreed on with the FDA.
The table below describes the cardiovascular safety results
using the post-hoc stratification factors reported at the American
Society of Nephrology conference in November 2019, as well as the
analyses with the pre-specified stratification factors which have
not been previously publicly reported.
|
|
Analyses with post-hoc stratification factors |
Analyses with pre-specified stratification
factors |
|
|
HR (95% Confidence Interval) |
HR (95% Confidence Interval) |
Non Dialysis (OLYMPUS, ANDES, ALPS N=4,270);
ITT |
|
MACE |
1.08 (0.94, 1.24) |
1.10 (0.96, 1.27) |
MACE+ |
1.04 (0.91, 1.18) |
1.07 (0.94, 1.21) |
ACM |
1.06 (0.91, 1.23) |
1.08 (0.93, 1.26) |
Dialysis Dependent (HIMALAYAS, SIERRAS,
ROCKIES N=3,880); OT-7 |
MACE |
0.96 (0.82, 1.13) |
1.02 (0.88, 1.20) |
MACE+ |
0.86 (0.74, 0.98) |
0.91 (0.80, 1.05) |
ACM |
0.96 (0.79, 1.17) |
1.02 (0.84, 1.23) |
|
Incident Dialysis (N=1,526); OT-7 |
|
|
MACE |
0.70 (0.51, 0.96) |
0.82 (0.60, 1.11) |
|
MACE+ |
0.66 (0.50, 0.89) |
0.78 (0.59, 1.02) |
|
ACM |
0.76 (0.52, 1.11) |
0.82 (0.57, 1.18) |
|
|
ITT: intention to
treat with long-term follow up |
OT-7: on-treatment
plus 7 days |
Major Adverse
Cardiovascular Event (MACE): a composite endpoint of all-cause
mortality, stroke, and myocardial infarction. |
(MACE+): in
addition to the components in MACE, includes hospitalization due to
heart failure or unstable angina. |
(ACM): all-cause
mortality. |
As reflected in the table, the analyses with the pre-specified
stratification factors result in higher hazard ratios (point
estimates of relative risk) and 95% confidence intervals. For MACE+
in dialysis and for MACE and MACE+ in incident dialysis, the 95%
confidence intervals include 1.0. While these hazard ratios remain
below 1.0, based on these analyses we cannot conclude that
roxadustat reduces the risk of (or is superior to) MACE+ in
dialysis, and MACE and MACE+ in incident dialysis compared to
epoetin-alfa.
These analyses do not change the Company’s assessment that
roxadustat is comparable to placebo in non-dialysis dependent
patients and to epoetin-alfa in dialysis dependent patients using
MACE to measure cardiovascular safety.
As previously announced, roxadustat has been launched in China
and Japan for the treatment of anemia of CKD in both NDD and DD
adult patients. These approvals were based on different studies
conducted in the relevant geographies. 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 FibroGen’s partner Astellas and accepted by the European
Medicines Agency for review in May 2020.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, April 6,
2021, at 5:00 pm Eastern Time (2:00 p.m. Pacific Time) to discuss
this matter. Interested parties may access a live audio webcast of
the conference call via the FibroGen website at
https://fibrogen.gcs-web.com/events-and-presentations/events. It is
recommended that listeners access the website 15 minutes prior to
the start of the call to download and install any necessary audio
software.
Dial-In InformationLive (U.S./Canada): (877) 658-9081Live
(International): (602) 563-8732Confirmation number: 5297733
A replay of the webcast and investor presentation will be
available shortly after the call for a period of 30 days. To access
the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406
(international), and use passcode 5297733.
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
Harrington+1.610.574.9196Jennifer.Harrington@gcihealth.com
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