Committee for Medicinal Products for Human Use
(CHMP) recommends approval of the conditional marketing
authorization (CMA) for sparsentan for the treatment of IgA
nephropathy (IgAN) in Europe
Positive CHMP opinion is based on pivotal
phase-III PROTECT study results
European Commission decision is expected in Q2
2024
ST. GALLEN, Switzerland, Feb. 23,
2024 /PRNewswire/ -- CSL Vifor and Travere
Therapeutics, Inc., (NASDAQ: TVTX) today announced that the
European Medicines Agency's (EMA) CHMP has recommended approval of
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). IgAN is a rare kidney
disorder and a leading cause of kidney failure. The CHMP opinion
provides the basis for the European Commission's final decision
regarding CMA for sparsentan. If approved in Europe, sparsentan will be the first
non-immunosuppressive, single-molecule, dual endothelin angiotensin
receptor antagonist for the treatment of IgAN.
"The positive CHMP opinion for sparsentan is one step closer to
bringing this treatment option to patients in Europe with IgAN, a rare and serious condition
that can cause kidney disease," said Emmanuelle Lecomte Brisset, Senior Vice
President and Head of Global Regulatory Affairs at CSL. "We look
forward to the European Commission decision and to continuing to
advance CSL's promise to provide innovative treatments for patients
with kidney disease."
"The positive recommendation from the CHMP represents a
significant advancement towards the delivery of new treatment
options for people living with IgAN, who face the risk of
progression to kidney failure and who currently have no approved
non-immunosuppressive treatment options. The PROTECT Study is the
only head-to-head study in IgAN against a maximally labeled dose of
irbesartan, a current standard of care. The study demonstrated
treatment with sparsentan resulted in a rapid and sustained
reduction in proteinuria and has the potential to preserve kidney
function and significantly delay time to kidney failure compared to
an active comparator, suggesting long-term benefits in IgAN," said
Eric Dube, Ph.D., president and chief executive officer of
Travere Therapeutics. "Together with CSL Vifor, we look forward to
the European Commission's decision in the second quarter of
2024."
The positive CHMP opinion is based on results from the pivotal
phase-III PROTECT study of sparsentan in IgAN, In August 2022, CSL Vifor and Travere Therapeutics
announced they had submitted a Marketing Authorization Application
(MAA) for CMA to the EMA. The European Commission previously
granted Orphan Medicinal Product Designation to sparsentan for the
treatment of IgAN.
If approved, sparsentan would receive a CMA in all member
states of the European Union, as well as
in Iceland, Liechtenstein and Norway.
Sparsentan is currently marketed in the U.S. and granted
accelerated approval by the U.S. Food and Drug Administration under
the brand name FILSPARI® based on reduction in
proteinuria.
In 2021, Travere Therapeutics granted CSL Vifor exclusive
commercialization rights for sparsentan in Europe, Australia and New
Zealand.
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.
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.
About sparsentan
Sparsentan 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. Sparsentan is currently available in the US and
was granted accelerated approval by the US Food and Drug
Administration in February 2023 under
the brand name FILSPARI® based on reduction in
proteinuria. In September 2023,
Travere Therapeutics reported two-year confirmatory results from
the Phase 3 PROTECT Study of FILSPARI in IgAN.
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SOURCE Vifor International AG (CSL Vifor)