First non-immunosuppressive therapy for
the treatment of IgA Nephropathy (IgAN) approved in Europe
Conditional marketing authorization is based
on statistically significant and clinically meaningful results from
the phase-III PROTECT trial
ST. GALLEN,
Switzerland and SAN DIEGO, April 24,
2024 /PRNewswire/ -- CSL Vifor and Travere
Therapeutics, Inc., (NASDAQ: TVTX) today announced that the
European Commission has granted conditional marketing authorization
(CMA) for FILSPARI (sparsentan) for the treatment of adults with
primary IgAN with a urine protein excretion ≥1.0 g/day (or urine
protein-to-creatinine ratio ≥0.75 g/g). The CMA is granted for all
member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
"This is a significant step forward for patients in Europe living with IgAN, a rare and serious
condition, and a leading cause of end stage renal disease," said
Prof. Dr. med. Jürgen Floege, Senior Professor, Div. Nephrology and
Clinical Immunology at the University Hospital, RWTH Aachen,
Germany, and steering committee
member for the PROTECT clinical trial. "The approval of this
innovative treatment is based on data from the only head-to-head
phase-III clinical trial in IgAN. Adult patients with IgAN who are
at high risk of progressing to kidney failure will now have access
to a new therapy that significantly reduces proteinuria and slows
the progression of kidney disease."
"The approval by the European Commission is an important
milestone for the IgAN community in Europe and underscores our promise to develop
and deliver innovative medicines in our areas of focus where there
is unmet need," said Emmanuelle Lecomte
Brisset, Senior Vice President and Head of Global Regulatory
Affairs at CSL. "We look forward to working with our partners and
EU member states to bring this innovative therapy to patients in
Europe."
"As the first and only non-immunosuppressive therapy approved
for IgAN, we believe FILSPARI offers clinicians the potential for a
new foundational treatment for this rare kidney disease, replacing
RAAS inhibition," said Eric Dube,
Ph.D., President and Chief Executive Officer, Travere Therapeutics.
"With this approval and the commercial strength and expertise of
our partner, CSL Vifor, we look forward to people living with IgAN
in Europe gaining access to this
important medicine."
The European Commission's decision follows the Committee for
Medicinal Products for Human Use (CHMP)'s positive opinion
in February 2024, based on results from the pivotal phase-III
PROTECT study of FILSPARI in IgAN. The PROTECT study met its
primary endpoint at the pre-specified interim analysis with
statistical significance. After 36 weeks of treatment, patients
receiving FILSPARI achieved a mean reduction in proteinuria from
baseline of 49.8 percent, compared to a mean reduction in
proteinuria from baseline of 15.1 percent for irbesartan-treated
patients. The two-year confirmatory results from the study showed
treatment with FILSPARI achieved statistical significance on the
eGFR chronic slope endpoint versus irbesartan and demonstrated
clinically meaningful kidney function preservation.
CSL Vifor expects to launch FILSPARI in the first European
markets in the second half of 2024.
About CSL Vifor
CSL Vifor is a global partner of choice for pharmaceuticals
and innovative, leading therapies in iron deficiency and
nephrology. We specialize in strategic global partnering,
in-licensing and developing, manufacturing and marketing
pharmaceutical products for precision healthcare, aiming to help
patients around the world lead better, healthier lives.
Headquartered in St. Gallen, Switzerland, CSL Vifor also
includes the joint company Vifor Fresenius Medical Care Renal
Pharma (with Fresenius Medical Care).
The parent company, CSL (ASX: CSL; USOTC: CSLLY),
headquartered in Melbourne, Australia, employs 32,000 people and
delivers its lifesaving therapies to people in more than 100
countries. For more information about CSL Vifor
visit, www.cslvifor.com.
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.
About IgA Nephropathy (IgAN)
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 glomerular disease
worldwide and a leading cause of kidney failure. IgAN is estimated
to affect up to 250,000 people in the licensed territories
(Europe, Australia and New
Zealand)
About the PROTECT study
The PROTECT Study is one of the largest interventional studies
to date in IgA nephropathy (IgAN) and the only head-to-head trial
in this rare kidney disease. It is a global, randomized,
multicenter, double-blind, parallel-arm, active-controlled clinical
trial evaluating the safety and efficacy of 400 mg of sparsentan,
compared to 300 mg of irbesartan, in 404 patients ages 18 years and
up with IgAN and persistent proteinuria despite receiving maximum
tolerated dose and at least 50% of maximum labelled dose of ACE or
ARB therapy. In August 2021, Travere announced the PROTECT
Study met its primary endpoint at the pre-specified interim
analysis . Based on the pre-specified, primary analyses set,
after 36 weeks of treatment, patients receiving sparsentan achieved
a mean reduction in proteinuria from baseline of 49.8%, compared to
a mean reduction in proteinuria from baseline of 15.1% for
irbesartan-treated patients (p<0.0001). The study's confirmatory
secondary endpoint in the EU is eGFR chronic slope, measured from
week 6 to week 110 of treatment, following the initial acute effect
of randomized treatment. The confirmatory secondary endpoint in
the U.S. is eGFR total slope from day 1 to week 110 of
treatment. In September 2023, Travere announced topline
two-year confirmatory secondary endpoint results from the
PROTECT Study of sparsentan in IgAN. Sparsentan demonstrated
long-term kidney function preservation and achieved a clinically
meaningful difference in eGFR chronic and total slope versus
irbesartan achieving statistical significance in eGFR chronic slope
for purposes of regulatory review in the EU, and narrowly missing
statistical significance in eGFR total slope. Patients who
completed the PROTECT double-blind portion of the study on
treatment were eligible to participate in the open-label extension
of the trial. In PROTECT, the most common adverse reactions (≥
5%) were peripheral edema, hypotension (including orthostatic
hypotension), dizziness, hyperkalemia, and anemia.
About FILSPARI (sparsentan)
FILSPARI is a novel, non-immunosuppressive, single-molecule,
dual endothelin angiotensin receptor antagonist with high
selectivity for the endothelin A receptor (ETAR) and the
angiotensin II subtype 1 receptor (AT1R). Pre-clinical data have
shown that blockade of both endothelin type A and angiotensin II
type 1 pathways in forms of rare chronic kidney disease, protects
podocytes, prevents glomerulosclerosis and mesangial cell
proliferation, and reduces proteinuria.
For more information please refer to the product overview on the
European Medicines Agency website.
FILSPARI was developed by Travere Therapeutics and has been
granted Orphan Drug Designation for the treatment of IgAN in
Europe and the U.S. FILSPARI is
currently available in the U.S. and was granted accelerated
approval by the US Food and Drug Administration in February 2023 based on reduction in proteinuria.
CSL Vifor has been granted exclusive commercialization rights for
FILSPARI in Europe, Australia and New
Zealand.
CSL Vifor Media
Contact
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Thomas Hutter
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+41 79 957 96
73
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media@viforpharma.com
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Travere
Therapeutics:
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Investors:
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Media:
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888-969-7879
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888-969-7879
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ir@travere.com
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mediarelations@travere.com
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SOURCE Vifor International AG (CSL Vifor)