VYVGART is the first neonatal Fc receptor (FcRn)
blocker approved in Europe for the treatment of adults living with
generalized myasthenia gravis (gMG) who are anti-acetylcholine
receptor (AChR) antibody positive
68% of anti-AChR antibody positive gMG patients
treated with VYVGART were responders (n=44/65) on the Myasthenia
Gravis Activities of Daily Living (MG-ADL) scale compared with 30%
of patients treated with placebo (n=19/64) (p<0.0001) during the
first treatment cycle in the Phase 3 ADAPT trial
argenx is committed to collaborating with local
authorities across the European Union to enable broad access to
VYVGART for eligible patients
August 11, 2022
Breda, the Netherlands —
argenx (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) has granted marketing authorization for VYVGART™ (efgartigimod
alfa-fcab) 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.
The approval is applicable to all 27 European Union (EU) Member
States plus Iceland, Norway and Liechtenstein. argenx will work
with local health authorities to secure market access for VYVGART
across the EU.
“Now, for the first time, people living with gMG in the EU will
have a treatment option that is targeted to the biology of their
disease, well-tolerated, and effective in managing symptoms. We are
proud to bring the first-and-only approved FcRn blocker to the EU
on the heels of our U.S. and Japan launches, and remain steadfast
in our mission to make VYVGART available to patients across the
globe," said Tim Van Hauwermeiren, Chief Executive Officer of
argenx. “We are also committed to supporting broad access to our
innovative therapy, and look forward to collaborating with local
health authorities to secure sustainable access agreements so we
can help alleviate the burden of this debilitating disease for as
many eligible patients as possible across the
EU.”
The EC approval of VYVGART is based on results from the global
Phase 3 ADAPT trial, which were published in the July 2021 issue of
The Lancet Neurology. The ADAPT trial met its primary endpoint,
demonstrating that significantly more anti-AChR antibody positive
gMG patients were responders on the Myasthenia Gravis Activities of
Daily Living (MG-ADL) scale following treatment with efgartigimod
compared with placebo (68% vs. 30%; p<0.0001). Responders were
defined as having at least a two-point reduction on the MG-ADL
scale sustained for four or more consecutive weeks during the first
treatment cycle.
There were also significantly more responders on the
Quantitative Myasthenia Gravis (QMG) scale following treatment with
efgartigimod compared with placebo (63% vs. 14%; p<0.0001).
Responders were defined as having at least a three-point reduction
on the QMG scale sustained for four or more consecutive weeks
during the first treatment cycle.
VYVGART had a demonstrated safety profile in the ADAPT clinical
trial. The most commonly reported adverse reactions were upper
respiratory tract infections (10.7% following treatment with
efgartigimod vs. 4.8% of placebo) and urinary tract infections
(9.5% vs. 4.8%).
“People living with gMG in the EU have long faced a significant
unmet medical need due to limitations of commonly used therapies.
The EC approval of VYVGART adds an important new tool for
clinicians providing care to these patients with a demonstrated
efficacy and safety profile observed in clinical trials,” said
Renato Mantegazza, M.D., Professor at the Department of
Neuroimmunology and Neuromuscular Diseases, Fondazione IRCCS
Istituto Neurologico Carlo Besta, Milan, Italy, and ADAPT trial
investigator. “Living with gMG can severely impair a person’s
ability to complete basic personal tasks. Now, patients and
families living with the devastating impact of this disease have an
effective treatment option that may help to significantly improve
their quality of life.”
VYVGART is the first-and-only approved FcRn blocker in the U.S.
and the EU for the treatment of adult gMG patients who are
anti-AChR antibody positive, and in Japan for patients who do not
have sufficient response to steroids or non-steroidal
immunosuppressive therapies (ISTs). argenx’s plans remain on track
to launch VYVGART in Canada, China through its collaboration with
Zai Lab, and select additional regions.
About Phase 3 ADAPT TrialThe Phase 3 ADAPT
trial was a 26-week randomized, double-blind, placebo-controlled,
multi-center, global trial evaluating the safety and efficacy of
efgartigimod in adult patients with gMG. A total of 167 adult
patients with gMG in North America, Europe and Japan enrolled in
the trial. Patients were randomized in a 1:1 ratio to receive
efgartigimod or placebo, in addition to stable doses of their
current gMG treatment. ADAPT was designed to enable an
individualized treatment approach with an initial treatment cycle
followed by subsequent treatment cycles based on clinical
evaluation. The primary endpoint was the comparison of percentage
of MG-ADL responders in the first treatment cycle between
efgartigimod and placebo treatment groups in the anti-AChR antibody
positive population.
About VYVGARTVYVGART (efgartigimod alfa-fcab)
is a human IgG1 antibody fragment that binds to the neonatal Fc
receptor (FcRn), resulting in the reduction of circulating
immunoglobulin G (IgG) autoantibodies. It is the first and only
approved FcRn blocker. VYVGART is approved in the United States and
Europe for the treatment of adults with generalized myasthenia
gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody
positive, and in Japan for the treatment of adults with gMG who do
not have sufficient response to steroids or non-steroidal
immunosuppressive therapies (ISTs).
About Generalized Myasthenia GravisGeneralized
myasthenia gravis (gMG) is a rare and chronic autoimmune disease
where IgG autoantibodies disrupt communication between nerves and
muscles, causing debilitating and potentially life-threatening
muscle weakness. Approximately 85% of people with MG progress to
gMG within 24 months1, where muscles throughout the body may be
affected. Patients with confirmed AChR antibodies account for
approximately 85% of the total gMG population1.
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 commercializing the first-and-only approved neonatal Fc receptor
(FcRn) blocker in the U.S., the EU and Japan.
For further information, please contact:
Media:Kelsey Kirkkkirk@argenx.com
Investors:Beth
DelGiaccobdelgiacco@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 “believes,” “hope,” “estimates,” “anticipates,”
“expects,” “intends,” “may,” “will,” or “should” and include
statements argenx makes concerning the approval by the EC of
VYVGART™ (efgartigimod alfa-fcab) 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 and argenx’s ability to collaborate with local authorities
across the European Union to enable broad access to VYVGART for
eligible patients, as well as argenx’s plans for launch in other
regions. 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. 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 publicly update or revise the information in this press
release, including any forward-looking statements, except as may be
required by law.
1 Behin et al. New Pathways and Therapeutics Targets in
Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277
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