- VYVGART® SC, first-and-only IgG Fc-antibody
fragment which specifically targets the neonatal Fc receptor
(FcRn), now approved for use in Europe for CIDP
- Approval based on ADHERE clinical trial, the largest study of
CIDP patients to date
- First novel mechanism of action for CIDP treatment in more than
30 years
June 20, 2025, 7:00 PM CET
Amsterdam, the Netherlands – argenx SE
(Euronext & Nasdaq: ARGX), a global immunology company
committed to improving the lives of people suffering from severe
autoimmune diseases, today announced that the European Commission
(EC) approved VYVGART® (efgartigimod alfa) 1000mg for subcutaneous
(SC) injection as a monotherapy for the treatment of adult patients
with progressive or relapsing active chronic inflammatory
demyelinating polyneuropathy (CIDP) after prior treatment with
corticosteroids or immunoglobulins. VYVGART for SC injection is
available as a vial or prefilled syringe and can be administered by
a patient, caregiver, or healthcare professional. Treatment is
initiated with a weekly dose regimen and may be adjusted to every
other week based on clinical evaluation.
"The EC’s decision has been met with hope and
enthusiasm by the European Patient Organisation for Dysimmune and
Inflammatory Neuropathies (EPODIN). We see the introduction of a
new targeted therapy for CIDP as a major step forward for the
patient community," said Jean-Philippe Plançon, President of
EPODIN.
CIDP is a rare, debilitating, often progressive,
immune-mediated neuromuscular disorder of the peripheral nervous
system. Patients experience a range of disabling mobility and
sensory issues, including trouble standing from a seated position,
pain and fatigue, and frequent tripping or falling. People living
with CIDP can also become wheelchair bound and unable to work as
the disease progresses. Currently, 85% of patients require ongoing
treatment and nearly 88% of treated patients experience residual
impairment and disability.
“CIDP can severely affect quality of life by
causing weakness, loss of balance and mobility, numbness and pain
in a patient’s arms and legs. For far too long, physicians have had
limited options for helping to improve patient outcomes,” said Dr.
Luis Querol, M.D., Ph.D., ADHERE Investigator, Hospital de la Santa
Creu i Sant Pau, Barcelona, Spain. “The approval of VYVGART SC for
the treatment of CIDP marks a turning point in clinical practice,
as physicians now have access to a new, effective treatment option
that, for the first time, precisely targets a key mechanism of
disease and provides meaningful functional improvements to
patients.”
The EC approval follows a positive
recommendation from the Committee for Medicinal Products for Human
Use (CHMP) and is based on positive results from the ADHERE
clinical trial, the largest study of CIDP patients to date. In the
study, 66.5% (214/322) of patients treated with VYVGART SC
demonstrated evidence of clinical improvement, including in
mobility, function and strength. Clinical benefit was seen across
all patient subtypes, regardless of prior treatment. ADHERE met its
primary endpoint (p<0.0001) demonstrating a 61% reduction (HR:
0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo. 99%
of trial participants elected to participate in the ADHERE
open-label extension. The safety results were consistent with the
known safety profile of VYVGART SC in previous clinical
studies.
“VYVGART SC is the first therapy with a novel mechanism of
action to be approved for this community in more than 30 years,”
said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx.
“With VYVGART SC, CIDP patients and physicians across Europe will
soon have access to an effective novel therapy with a
favorable safety profile that has a precise mechanism of action and
a convenient self-injection option. This approval further affirms
the potential of efgartigimod in IgG-mediated autoimmune
diseases.”
The EC approval will apply to all 27 European
Union Member States, and also to Iceland, Liechtenstein, and
Norway. argenx is working closely with local regulatory authorities
across the region to ensure that patients who may benefit from
VYVGART SC are able to access the novel treatment as soon as
possible.
This regulatory approval is the second for
VYVGART SC in Europe, which first received approval as an add-on to
standard therapy for the treatment of adult patients with
generalized myasthenia gravis (gMG) who are anti-acetylcholine
receptor (AChR) antibody positive. About
ADHERE The ADHERE trial was a multi-center, randomised,
double-blind, placebo-controlled trial evaluating efgartigimod alfa
SC for the treatment of CIDP. ADHERE enrolled 322 adult patients
with CIDP, 130 of whom were based in Europe. The trial consisted of
an open-label Stage A followed by a randomized, placebo-controlled
Stage B. In order to be eligible for the trial, the diagnosis of
CIDP was confirmed by an independent panel of experts. Patients
entered a run-in stage, where any ongoing CIDP treatment was
stopped and, in order to be eligible for Stage A, had to
demonstrate active disease with clinically meaningful worsening on
at least one CIDP clinical assessment tool, including INCAT,
I-RODS, or mean grip strength. Treatment-naïve patients were able
to skip the run-in period with proof of recent worsening. To
advance to Stage B, patients needed to demonstrate evidence of
clinical improvement (ECI) with efgartigimod alfa SC. ECI was
achieved through improvement of the INCAT score, or improvement on
I- RODS or mean grip strength if those scales had demonstrated
worsening during the run-in period. In Stage B, patients were
randomized to either efgartigimod alfa SC or placebo for up to 48
weeks. The primary endpoint was measured once 88 total relapses or
events were achieved in Stage B and was based on the hazard ratio
for the time to first adjusted INCAT deterioration (i.e. relapse).
After Stage B, all patients had the option to roll-over to an
open-label extension study to receive efgartigimod alfa SC.
About Chronic Inflammatory Demyelinating Polyneuropathy
(CIDP)CIDP is a rare and serious autoimmune disease of the
peripheral nervous system. There is increasing evidence that IgG
antibodies play a key role in the damage to the peripheral nerves.
People with CIDP experience fatigue, muscle weakness and a loss of
feeling in their arms and legs that can worsen over time or may
come and go. These symptoms can significantly impair a person's
ability to function in their daily lives. Without treatment,
one-third of people living with CIDP will need a wheelchair.
About Efgartigimod SCEfgartigimod SC
(efgartigimod alfa) is a human IgG1 antibody fragment designed to
reduce pathogenic immunoglobulin G (IgG) antibodies by binding to
the neonatal Fc receptor (FcRn) and blocking the IgG recycling
process. Efgartigimod SC is the first-approved FcRn blocker
globally and is marketed as VYVGART® Hytrulo in the United States
and China for the treatment of generalized myasthenia gravis (gMG)
and CIDP; as VYVDURA in Japan for gMG and CIDP; and as VYVGART for
gMG and CIDP in other regions globally. Efgartigimod SC is
currently being evaluated in more than 15 severe autoimmune
diseases where pathogenic IgGs are believed to be mediators of
disease.
About argenxargenx is a global
immunology company committed to improving the lives of people
suffering from severe autoimmune diseases. Partnering with leading
academic researchers through its Immunology Innovation Program
(IIP), argenx aims to translate immunology breakthroughs into a
world-class portfolio of novel antibody-based medicines. argenx
developed and is commercialising the first approved neonatal Fc
receptor (FcRn) blocker and is evaluating its broad potential in
multiple serious autoimmune diseases while advancing several
earlier stage experimental medicines within its therapeutic
franchises. For more information, visit www.argenx.com and follow
us on LinkedIn, Instagram, Facebook, and YouTube.
Contacts
Media:Kate Dion kdion@argenx.com
Investors: Alexandra
Royaroy@argenx.com
Forward-Looking Statements
The contents of this announcement include
statements that are, or may be deemed to be, “forward-looking
statements.” These forward-looking statements can be identified by
the use of forward-looking terminology, including the terms “aim,”
“is,” “can,” “may,” “will,” and “believe” and include statements
argenx makes concerning argenx’s aim to translate immunology
breakthroughs into a world-class portfolio of novel antibody-based
medicines; its belief that the approval of VYVGART SC for the
treatment of CIDP may bring meaningful functional improvements to
patients; the timing of access to an effective novel therapy for
CIDP patients and physicians across Europe; and the potential of
efgartigimod in IgG-mediated autoimmune diseases. By their nature,
forward-looking statements involve risks and uncertainties and
readers are cautioned that any such forward-looking statements are
not guarantees of future performance. argenx’s actual results may
differ materially from those predicted by the forward-looking
statements as a result of various important factors, including but
not limited to, the results of argenx’s clinical trials;
expectations regarding the inherent uncertainties associated with
the development of novel drug therapies; preclinical and clinical
trial and product development activities and regulatory approval
requirements; the acceptance of its products and product candidates
by its patients as safe, effective and cost-effective; the impact
of governmental laws and regulations, including tariffs, export
controls, sanctions and other regulations on its business; its
reliance on third-party suppliers, service providers and
manufacturers; inflation and deflation and the corresponding
fluctuations in interest rates; and regional instability and
conflicts. A further list and description of these risks,
uncertainties and other risks can be found in argenx’s U.S.
Securities and Exchange Commission (SEC) filings and reports,
including in argenx’s most recent annual report on Form 20-F filed
with the SEC as well as subsequent filings and reports filed by
argenx with the SEC. Given these uncertainties, the reader is
advised not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only as of the
date of publication of this document. argenx undertakes no
obligation to publicly update or revise the information in this
press release, including any forward-looking statements, except as
may be required by law.
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