Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the
Company will present nine abstracts in rare kidney disease at the
World Congress of Nephrology (WCN) in Buenos Aires, Argentina, on
April 13-16, 2024, and the American Nephrology Nurses Association
(ANNA) National Symposium in Orlando, Florida, on April 14-17,
2024.
At WCN, the Company will present subgroup
analyses of the Phase 3 PROTECT Study of FILSPARI® (sparsentan) in
IgA nephropathy (IgAN) showing the treatment effect across
participants with different levels of baseline proteinuria. Encore
presentations will include preliminary findings from the SPARTAN
Study supportive of FILSPARI as a first-line treatment for patients
with IgAN, as well as the early clinical experience from the
PROTECT open-label extension regarding the addition of
sodium-glucose cotransporter-2 inhibitors (SGLT2i) to ongoing
FILSPARI treatment in patients with IgAN. At ANNA, the Company will
present additional insights from the HONUS trial, including
health-related quality of life (HRQoL) data and the humanistic
burden experienced by patients with IgAN and focal segmental
glomerulosclerosis (FSGS).
“The data we are presenting at WCN and ANNA
reinforce the wealth of evidence supporting FILSPARI’s profile to
become an effective foundational treatment replacing RAAS
inhibition, with the potential to reduce the lifetime risk of
kidney failure for patients with IgAN,” said Jula Inrig, M.D.,
chief medical officer of Travere Therapeutics. “We are also looking
forward to presenting data that address broader aspects of disease
management, building upon Travere’s holistic approach to improving
patient outcomes in RKD.”
WCN Late Breaking Abstract
Sparsentan vs Irbesartan in Patients
with Immunoglobulin A Nephropathy (IgAN): Subgroup Analyses of
2-Year Results from the Pivotal Phase 3 PROTECT TrialOral
Presentation: MON-296Late Breaking Clinical Trial Session
Exhibition Hall and Main Foyer; April 15, 2024, 3:35-3:45 p.m.
ART
WCN Poster Presentations
Sparsentan as First-Line Treatment of
Incident Patients with IgA Nephropathy: Preliminary Findings from
the SPARTAN TrialPoster: SUN-042Poster Session: Clinical
Glomerulonephritis 2Exhibition Hall and Main Foyer; April 14, 2024,
5:45-6:45 p.m. ART
Concomitant Sparsentan and
Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in Patients with
IgA Nephropathy (IgAN) in the PROTECT Open-Label Extension
(OLE)Poster: SUN-049Poster Session: Clinical
Glomerulonephritis 2 Exhibition Hall and Main Foyer; April 14,
2024, 5:45-6:45 p.m. ART
Sparsentan Receptor Occupancy Modeling,
Clinical Actions, and Safety Poster: SUN-045Poster
Session: Clinical Glomerulonephritis 2Exhibition Hall and Main
Foyer; April 14, 2024, 5:45-6:45 p.m. ART
Preliminary Findings from the Phase 2
EPPIK Study of Sparsentan in Pediatric Patients with Selected
Proteinuric Glomerular DiseasesPoster: SUN-048Poster
Session: Clinical Glomerulonephritis 2Exhibition Hall and Main
Foyer; April 14, 2024, 5:45-6:45 p.m. ART
ANNA Poster Presentations
Sparsentan (SPAR), a Novel
Non-immunosuppressive Therapy for Patients (pts) with
Immunoglobulin A Nephropathy (IgAN): Pivotal Phase 3 PROTECT Trial
DataExhibit Hall; April 15, 2024, 8:45-10:15 a.m. &
2:30-4 p.m.; April 16, 2024, 8:45-10:15 a.m. ET
Contextualizing the Humanistic Burdens
of Focal Segmental Glomerular Sclerosis (FSGS) in HONUS Compared to
External Controls in NHWSExhibit Hall; April 15, 2024,
8:45-10:15 a.m. & 2:30-4 p.m.; April 16, 2024, 8:45-10:15 a.m.
ET
Indirect Comparisons of Humanistic
Burdens Between Patients with Immunoglobulin A Nephropathy (IgAN)
from HONUS and External Controls from NHWSExhibit Hall;
April 15, 2024, 8:45-10:15 a.m. & 2:30-4 p.m.; April 16, 2024,
8:45-10:15 a.m. ET
Data in Kidney Failure (KF) Estimated by
Treatment Effects on Proteinuria in Patients with Immunoglobulin A
Nephropathy (IgAN)Exhibit Hall; April 15, 2024, 8:45-10:15
a.m. & 2:30-4 p.m.; April 16, 2024, 8:45-10:15 a.m. ET
About IgA Nephropathy
IgA nephropathy (IgAN), also called Berger's
disease, is a rare progressive kidney disease characterized by the
buildup of immunoglobulin A (IgA), a protein that helps the body
fight infections, in the kidneys. The deposits of IgA cause a
breakdown of the normal filtering mechanisms in the kidney, leading
to blood in the urine (hematuria), protein in the urine
(proteinuria) and a progressive loss of kidney function. Other
symptoms of IgAN may include swelling (edema) and high blood
pressure.
IgAN is the most common type of primary
glomerulonephritis worldwide and a leading cause of kidney failure
due to glomerular disease. IgAN is estimated to affect up to
150,000 people in the U.S. and is one of the most common
glomerular diseases in Europe and Japan.
About Travere Therapeutics
At Travere Therapeutics, we are in rare for
life. We are a biopharmaceutical company that comes together every
day to help patients, families and caregivers of all backgrounds as
they navigate life with a rare disease. On this path, we know the
need for treatment options is urgent – that is why our global team
works with the rare disease community to identify, develop and
deliver life-changing therapies. In pursuit of this mission, we
continuously seek to understand the diverse perspectives of rare
patients and to courageously forge new paths to make a difference
in their lives and provide hope – today and tomorrow. For more
information, visit travere.com
FILSPARI® (sparsentan) U.S. Indication
FILSPARI is an endothelin and angiotensin II
receptor antagonist indicated to reduce proteinuria in adults with
primary immunoglobulin A nephropathy (IgAN) at risk of rapid
disease progression, generally a UPCR ≥1.5 g/g.
This indication is granted under accelerated
approval based on reduction in proteinuria. It has not been
established whether FILSPARI slows kidney function decline in
patients with IgAN. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
a confirmatory clinical trial.
FILSPARI® (sparsentan)
Important Safety Information
BOXED WARNING: HEPATOTOXICITY AND
EMBRYO-FETAL TOXICITYBecause of the risks of
hepatotoxicity and birth defects, FILSPARI is available only
through a restricted program called the FILSPARI REMS. Under the
FILSPARI REMS, prescribers, patients and pharmacies must enroll in
the program.
HepatotoxicitySome
Endothelin Receptor Antagonists (ERAs) have caused elevations of
aminotransferases, hepatotoxicity, and liver failure. In clinical
studies, elevations in aminotransferases (ALT or AST) of at least
3-times the Upper Limit of Normal (ULN) have been observed in up to
2.5% of FILSPARI-treated patients, including cases confirmed with
rechallenge.
Measure transaminases and bilirubin
before initiating treatment and monthly for the first 12 months,
and then every 3 months during treatment. Interrupt treatment and
closely monitor patients who develop aminotransferase elevations
more than 3x ULN.
FILSPARI should generally be avoided in
patients with elevated aminotransferases (>3x ULN) at baseline
because monitoring for hepatotoxicity may be more difficult and
these patients may be at increased risk for serious
hepatotoxicity.
Embryo-Fetal
ToxicityFILSPARI can cause major birth defects if
used by pregnant patients based on animal data. Therefore,
pregnancy testing is required before the initiation of treatment,
during treatment and one month after discontinuation of treatment
with FILSPARI. Patients who can become pregnant must use effective
contraception before the initiation of treatment, during treatment,
and for one month after discontinuation of treatment with
FILSPARI.
Contraindications: FILSPARI is
contraindicated in patients who are pregnant. Do not coadminister
FILSPARI with angiotensin receptor blockers (ARBs), ERAs, or
aliskiren.
Warnings and Precautions
Hepatotoxicity: Elevations in
ALT or AST of at least 3-fold ULN have been observed. To reduce the
risk of potential serious hepatotoxicity, measure serum
aminotransferase levels and total bilirubin prior to initiation of
treatment, monthly for the first 12 months, then every 3 months
during treatment.
Advise patients with symptoms suggesting
hepatotoxicity (nausea, vomiting, right upper quadrant pain,
fatigue, anorexia, jaundice, dark urine, fever, or itching) to
immediately stop treatment with FILSPARI and seek medical
attention. If aminotransferase levels are abnormal at any time
during treatment, interrupt FILSPARI and monitor as
recommended.
Consider re-initiation of FILSPARI only when
hepatic enzyme levels and bilirubin return to pretreatment values
and only in patients who have not experienced clinical symptoms of
hepatotoxicity.
Avoid initiation of FILSPARI in patients with
elevated aminotransferases (>3x ULN) prior to drug
initiation.
Embryo-Fetal
Toxicity: FILSPARI can cause fetal harm. Advise
patients who can become pregnant of the potential risk to a fetus.
Obtain a pregnancy test and advise patients who can become pregnant
to use effective contraception prior to, during, and one month
after discontinuation of FILSPARI treatment.
FILSPARI REMS: FILSPARI is
available only through a restricted program under a REMS called the
FILSPARI REMS. Important requirements include:
- Prescribers must be certified with the FILSPARI REMS by
enrolling and completing training.
- All patients must enroll in the FILSPARI REMS prior to
initiating treatment and comply with monitoring requirements.
- Pharmacies that dispense FILSPARI must be certified with the
FILSPARI REMS and must dispense only to patients who are authorized
to receive FILSPARI.
Further information is available
at www.filsparirems.com or 1-833-513-1325.
Hypotension: There was a
greater incidence of hypotension-associated adverse events, some
serious, including dizziness, in patients treated with FILSPARI
compared to irbesartan. In patients at risk for hypotension,
consider eliminating or adjusting other antihypertensive
medications and maintaining appropriate volume status. If
hypotension develops, consider a dose reduction or dose
interruption of FILSPARI.
Acute Kidney
Injury: Monitor kidney function periodically.
Patients whose kidney function may depend in part on the activity
of the renin-angiotensin system (e.g., patients with renal artery
stenosis, chronic kidney disease, severe congestive heart failure,
or volume depletion) may be at particular risk of developing acute
kidney injury on FILSPARI. Consider withholding or discontinuing
therapy in patients who develop a clinically significant decrease
in kidney function while on FILSPARI.
Hyperkalemia: Monitor
serum potassium periodically and treat appropriately. Patients with
advanced kidney disease, taking concomitant potassium-increasing
drugs (e.g., potassium supplements, potassium-sparing diuretics),
or using potassium-containing salt substitutes are at increased
risk for developing hyperkalemia. Dosage reduction or
discontinuation of FILSPARI may be required.
Fluid Retention: Fluid
retention may occur with ERAs, and has been observed with FILSPARI.
If clinically significant fluid retention develops, after
evaluation, consider modifying the dose of FILSPARI.
Most common adverse reactions (5%) with
FILSPARI are peripheral edema, hypotension (including
orthostatic hypotension), dizziness, hyperkalemia, and anemia.
Drug interactions
-
Renin-Angiotensin System (RAS) Inhibitors and
ERAs: Do not coadminister FILSPARI with angiotensin
receptor blockers (ARBs), ERAs, or aliskiren.
- Strong
and Moderate CYP3A Inhibitors: Avoid concomitant use
of FILSPARI with strong CYP3A inhibitors. Monitor blood pressure,
serum potassium, edema, and kidney function regularly when used
concomitantly with moderate CYP3A inhibitors.
- Strong
CYP3A Inducers: Avoid concomitant use with a strong
CYP3A inducer.
- Antacids
and Acid Reducing Agents: Administer FILSPARI 2 hours
before or after administration of antacids. Avoid concomitant use
of acid reducing agents (histamine H2 receptor antagonist and PPI
proton pump inhibitor) with FILSPARI.
-
Non-Steroidal Anti-Inflammatory Agents (NSAIDs), Including
Selective Cyclooxygenase-2 (COX-2)
Inhibitors: Monitor for signs of worsening renal
function.
- CYP2B6,
2C9, and 2C19 Substrates: Monitor for efficacy of the
concurrently administered CYP2B6, 2C9, and 2C19 substrates and
consider dosage adjustment in accordance with the Prescribing
Information.
- P-gp and
BCRP Substrates: Avoid concomitant use of sensitive
substrates of P-gp and BCRP with FILSPARI.
- Agents
Increasing Serum Potassium: Monitor serum potassium
frequently. Concomitant use of FILSPARI with potassium-sparing
diuretics, potassium supplements, potassium-containing salt
substitutes, or other drugs that raise serum potassium levels may
result in hyperkalemia.
Use in specific populations
-
Pregnancy / Females and Males of Reproductive
Potential: FILSPARI can cause fetal harm, including
birth defects and fetal death, when administered to a pregnant
patient and is contraindicated during pregnancy.
-
Pregnancy Testing / Contraception: Verify the
pregnancy status and effective method of contraception prior to,
during, and one month after discontinuation of FILSPARI treatment.
The patient should contact their physician immediately for
pregnancy testing if onset of menses is delayed or pregnancy is
suspected.
-
Lactation: Advise patients not to breastfeed
during treatment with FILSPARI.
- Hepatic
Impairment: Avoid use of FILSPARI in patients with
any hepatic impairment (Child-Pugh class A-C).
Please see Full Prescribing Information
for
FILSPARI here.
Forward Looking Statements
This press release contains “forward-looking
statements” as that term is defined in the Private Securities
Litigation Reform Act of 1995. Without limiting the foregoing,
these statements are often identified by the words “anticipate,”
“believe,” “expect,” “intend,” “may,” “might,” “objective,” “plan,”
“will” or similar expressions. In addition, expressions of our
strategies, intentions or plans are also forward-looking
statements. Such forward-looking statements include, but are not
limited to, statements regarding the potential for FILSPARI to
become a foundational treatment for IgAN replacing RAAS inhibition,
and its potential to reduce the lifetime risk of kidney failure for
patients with IgAN; and statements regarding the studies described
herein, including but not limited to future expectations,
preliminary findings and early clinical experience. Such
forward-looking statements are based on current expectations and
involve inherent risks and uncertainties, including factors that
could delay, divert or change any of them, and could cause actual
outcomes and results to differ materially from current
expectations. No forward-looking statement can be guaranteed. Among
the factors that could cause actual results to differ materially
from those indicated in the forward-looking statements are risks
and uncertainties associated with the regulatory review and
approval process, risks associated with enrollment of clinical
trials for rare diseases, and risks that ongoing or planned
clinical trials may not succeed or may be delayed for safety,
regulatory or other reasons. The Company faces risks related to its
business and finances in general; risks related to the commercial
launch of a new product; risks associated with market acceptance of
FILSPARI and other current and future products, including efficacy,
safety, price, reimbursement and benefit over competing therapies;
and the risk that the Company’s clinical candidates will not be
found to be safe or effective and that current or anticipated
future clinical trials will not proceed as planned. Specifically,
the Company faces risks related to the timing and potential outcome
of the FDA’s potential acceptance for filing and review of the sNDA
submission for full approval of FILSPARI in IgAN, and the timing
and potential outcome of the European Commission’s decision
regarding conditional marketing authorization of sparsentan for
IgAN. There is no guarantee that the FDA will accept the sNDA
submission for filing, that the European Commission will grant
conditional marketing authorization of sparsentan for IgAN, or that
regulators will grant full approval of sparsentan for IgAN or FSGS.
The Company also faces the risk that it will be unable to raise
additional funding that may be required to complete development of
any or all of its product candidates, including as a result of
macroeconomic conditions; risks relating to the Company's
dependence on contractors for clinical drug supply and commercial
manufacturing; uncertainties relating to patent protection and
exclusivity periods and intellectual property rights of third
parties; risks associated with regulatory interactions; and risks
and uncertainties relating to competitive products, including
current and potential future generic competition with certain of
the Company's products, and technological changes that may limit
demand for the Company's products. The Company also faces
additional risks associated with global and macroeconomic
conditions, including health epidemics and pandemics, including
risks related to potential disruptions to clinical trials,
commercialization activity, supply chain, and manufacturing
operations. You are cautioned not to place undue reliance on these
forward-looking statements as there are important factors that
could cause actual results to differ materially from those in
forward-looking statements, many of which are beyond our control.
The Company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events, or otherwise. Investors are referred to the full
discussion of risks and uncertainties, including under the heading
“Risk Factors”, as included in the Company’s most recent Form 10-K,
Form 10-Q and other filings with the Securities and Exchange
Commission.
Contact Info
Media:888-969-7879mediarelations@travere.com |
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Investors:888-969-7879IR@travere.com |
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