Full Press Release Details
argenx Announces VYVGART (efgartigimod alfa)
Authorized for Sale by Health Canada for Generalized Myasthenia Gravis
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
"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."
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 Gravis
Generalized 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
argenx 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
Twitter, and Instagram.
1 Behin et al. New Pathways and Therapeutics
Targets in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277
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Forward-looking Statements
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.