- VYVGARTⓇ
is the first-and-only neonatal Fc receptor (FcRn) blocker
authorized for sale in Canada
- Approval
based on the positive Phase 3 ADAPT trial (p<0.0001) showing 68%
of VYVGART-treated patients were responders on the MG-ADL scale
compared to 30% of placebo patients after one treatment cycle
Amsterdam, The Netherlands
—Sep.
21, 2023—argenx
SE (Euronext & Nasdaq: ARGX), a global immunology company
committed to improving the lives of people suffering from severe
autoimmune diseases, today announced that Health Canada has issued
a Notice of Compliance authorizing VYVGARTⓇ (efgartigimod alfa) for
the treatment of generalized myasthenia gravis (gMG) in adult
patients who are anti-acetylcholine receptor (AChR) antibody
positive. With this regulatory milestone, VYVGART is the
first-and-only neonatal Fc receptor (FcRn) blocker authorized for
sale in Canada.
“There continues to be a significant unmet
medical need for people living with gMG, who face debilitating
muscle weakness and mobility issues. We are very excited by the
authorization of VYVGART for sale in Canada, bringing a safe and
effective treatment option to patients and clinicians that targets
the underlying driver of gMG by reducing IgG autoantibodies,” said
Dr. Vera Bril, Professor of Medicine (Neurology) at the University
of Toronto, Director of the Neuromuscular Section, Division of
Neurology, University of Toronto and University Health Network.
“Living with gMG can significantly impact a
person’s independence and affect basic personal tasks, such as
speaking, chewing and swallowing food, and brushing teeth and hair,
and in some severe cases, it can also affect breathing. The gMG
community in Canada has long awaited new effective treatment
advancements for this rare condition. Today’s announcement brings
new hope for people with gMG, and we look forward to seeing the
important impact of this additional treatment option,” said Stacey
Lintern, Chief Executive Officer, Muscular Dystrophy Canada.
The authorization 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 MG-ADL scale
following treatment with VYVGART compared with placebo (68% vs.
30%; p<0.0001) and on the Quantitative Myasthenia Gravis (QMG)
scale (63% VYVGART vs. 14% placebo; p<0.0001).
VYVGART had a demonstrated safety profile in the
ADAPT clinical trial. The most common adverse events in ADAPT were
headache (29% vs 28% placebo), upper respiratory tract infection
(11% vs 5% placebo), and urinary tract infection (10% vs. 5%
placebo).
“Today is an important day for us as we deliver
on our commitment to the gMG community to make VYVGART available to
patients in Canada,” said John Haslam, General Manager argenx
Canada. “For the first time, people living with gMG in Canada will
have a treatment option that is targeted to the biology of their
disease, which is both well-tolerated and effective in managing
symptoms.”
About VYVGART
VYVGART is a human IgG1 antibody fragment that
binds to the neonatal Fc receptor (FcRn), resulting in the
reduction of circulating IgG autoantibodies. It is the first
approved FcRn blocker in the United States, EU and China 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 Phase 3 ADAPT Trial
The Phase 3 ADAPT trial was a 26-week
randomized, double-blind, placebo-controlled, multi-center, global
trial evaluating the safety and efficacy of VYVGART 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 VYVGART 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 VYVGART and placebo treatment groups in the
anti-AChR antibody positive population. 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.
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 months,1 where muscles
throughout the body may be affected. Patients with confirmed AChR
antibodies account for approximately 85% of the total gMG
population.1
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 approved neonatal Fc
receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK
and China. The Company is evaluating efgartigimod in multiple
serious autoimmune diseases and advancing several earlier stage
experimental medicines within its therapeutic franchises. For more
information, visit www.argenx.com and follow us on LinkedIn,
Twitter, and Instagram.
References1 Behin et al. New
Pathways and Therapeutics Targets in Autoimmune Myasthenia Gravis.
J Neuromusc Dis 5. 2018. 265-277
For further information, please
contact:
Media:
Erin MurphyEMurphy@argenx.com
Investors:
Alexandra Roy (US)ARoy@argenx.com
Lynn Elton (EU)LElton@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 availability of VYVGART® for sale in Canada;
the potential impact of VYVGART® on people living with gMG in
Canada; and the benefits and safety profile of VYVGART®. 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.
# # #
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