Scientific presentations demonstrate argenx’s
leadership in FcRn blockade and commitment to innovating for
patients across multiple neuromuscular diseases
Additional data from ADAPT+ open-label study
support long-term safety of VYVGART® (efgartigimod alfa-fcab) for
treatment of adult patients with generalized myasthenia gravis
(gMG), who experienced consistent improvements in function and
strength over multiple years
Pooled data from ADAPT studies and real-world
clinical setting suggest VYVGART treatment was associated with
clinically meaningful disease score improvements in seronegative
gMG patients
Amsterdam, the
Netherlands – September
21, 2022 argenx
SE (Euronext & Nasdaq: ARGX), a global immunology company
committed to improving the lives of people suffering from severe
autoimmune diseases, today announced the presentation of new data
from its neuromuscular franchise at the American Association of
Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting
(September 21-24, 2022) and the Myasthenia Gravis Foundation of
America (MGFA) Scientific Session (September 21, 2022), both being
held in Nashville, TN.
“We made a long-term commitment to the gMG
community to reach as many people as possible who are living with
this devastating disease, providing them with a new standard in
treatment. The data we are presenting this week further underscore
this commitment with a growing body of clinical safety and efficacy
data on VYVGART, our first-in-class FcRn blocker and the anchor of
our neuromuscular franchise. gMG is a disease that affects each
patient differently and that is exactly how we want to approach
treatment – meeting the needs of patients and physicians based on
their individual disease experience,” said Tim Van
Hauwermeiren, Chief Executive Officer, argenx. “Deeper within our
neuromuscular franchise, we are highlighting the thoughtful trial
designs of the ADHERE study of efgartigimod in CIDP and the ARDA
trial of ARGX-117 in MMN, bringing us one step closer to reaching
many more people suffering from severe autoimmune diseases.”
Highlights from AANEM and
MGFASeventeen scientific abstracts have been accepted
between both meetings, including previously reported data from the
ADAPT+ open-label extension study evaluating the long-term safety,
tolerability and efficacy of VYVGART and the registrational
ADAPT-SC trial evaluating the noninferiority of subcutaneous (SC)
efgartigimod compared to intravenously administered VYVGART based
on total IgG reduction. New data analyses from ADAPT+ and
real-world case studies are being presented on the adult
anti-acetylcholine receptor antibody negative (AChR-Ab-) gMG
patient population.
- ADAPT+: Data
suggest that long-term treatment with VYVGART provides consistent
decreases in IgG antibodies and repeatable improvements in function
and strength based on Myasthenia Gravis Activities of Daily Living
(MG-ADL) and Quantitative Myasthenia Gravis (QMG) disease scores;
the long-term safety profile of VYVGART remained consistent with
the Phase 3 ADAPT trial.
- ADAPT-SC: Topline
data show SC efgartigimod was noninferior to VYVGART in total IgG
reduction at day 29 and demonstrated consistent clinical
improvement based on MG-ADL and QMG disease scores.
- Seronegative gMG
Population: New pooled data from ADAPT+
and real-world case studies indicate that VYVGART treatment was
associated with clinically meaningful disease score improvements
(≥2-point improvement in MG-ADL and ≥3-point improvement in QMG) in
adult AChR-Ab- gMG patients. Clinically meaningful improvement in
MG-ADL scores was observed in AChR-Ab- patients across 10 treatment
cycles in ADAPT+. Additionally, preliminary real-world experience
in the AChR-Ab- patient population is largely consistent with the
ADAPT studies.
- gMG Disease and Treatment
Burden: Additional evidence from argenx-sponsored health
economic outcomes research studies demonstrate the severity of gMG
based on annual hospitalizations and readmission and mortality
rates, especially in older gMG patients.
- Vaccine
Response: Preliminary data suggest treatment with
VYVGART does not impact immune response to vaccinations, including
to COVID-19.
AANEM Poster Presentations
are taking place at the following times in Ryman Exhibit
Hall B1:
AANEM Session I: Thursday, 9/22
from 6:00 - 6:30 pm CTAANEM Session II: Friday,
9/23 from 9:30 - 10:00 am CTAANEM Session III:
Friday, 9/23 from 3:30 - 4:00 pm CT
VYVGART®
(efgartigimod alfa-fcab)
Long-Term Safety, Tolerability, and Efficacy of
Efgartigimod in Patients with Generalized Myasthenia Gravis:
Interim Results of the ADAPT+ Study
- James F. Howard Jr., M.D.
- Session I and III
Response to Coronavirus 2019 Vaccination in
Patients Receiving Efgartigimod
- James F. Howard Jr., M.D.
- Session I and II
Continuous and Fixed-Cycle Dosing of Intravenous
Efgartigimod for Generalized Myasthenia Gravis: Study Design of
ADAPT-NXT
- Kelly Gwathmey, M.D.
- Session I and II
Study Design of Intravenous Efgartigimod in
Juvenile Generalized Myasthenia Gravis
- Nancy L. Kuntz, M.D.
- Session I and III
The Effect of Obesity on Efficacy and Safety in
the ADAPT Trial of Efgartigimod for Generalized Myasthenia
Gravis
- Michael Pulley, M.D., Ph.D.
- Session I and II
Efficacy, Safety, And Tolerability of
Efgartigimod in Anti-Acetylcholine Receptor Autoantibody
Seronegative Patients with Generalized Myasthenia Gravis:
Integrated Interim Analysis of ADAPT and ADAPT+ Studies
- Tuan Vu, M.D.
- Session I and II
Effects of Efgartigimod Treatment on Humoral and
Cellular Immune Responses: Analysis of T-Cell-Dependent Antibody
Response in Cynomolgus Monkeys
- Deborah Gelinas, M.D., argenx
- Session I and II
Safety and Tolerability of Efgartigimod in
Patients with Generalized Myasthenia Gravis: Integrated Interim
Analysis of Infection Risk and Hematological Changes
- Srikanth Muppidi, M.D.
- Session I and II
Diagnostic Adjudication of Chronic Inflammatory
Demyelinating Polyneuropathy (CIDP) in the ADHERE Trial: Updates on
the First 200 Cases
- Richard A. Lewis, M.D.
- Session I and III
ARGX-117 (anti-C2 monoclonal
antibody)
Safety, Efficacy, and Pharmacokinetics of
ARGX-117 in Adults with Multifocal Motor Neuropathy: A Global,
Multicenter, Placebo Controlled Phase 2 Study (ARDA)
- Olivier van de Steen, M.D.,
argenx
- Session I and III
MGFA
Presentations are taking place at
the following times in Tennessee Ballroom
AB:
Oral Presentation: A
Pharmacodynamic Noninferiority Study Comparing Subcutaneous
Injections of Efgartigimod Ph20 with Intravenous Infusions of
Efgartigimod: Results of the Phase 3 ADAPT-SC Study
- James F. Howard Jr., M.D.
- September 21; 9:02am ET
Oral Presentation: Efficacy of
Efgartigimod Treatment in Patients With Anti-Acetylcholine Receptor
Antibody Negative Myasthenia Gravis: Clinical Trial and Real-World
Data
- Tania Beltran Papsdorf, M.D.
- September 21, Time: 10:57am ET
Oral Presentation: A Phase 3b
Open-Label Study to Further Individualize Efgartigimod Treatment
Options for Patients with Generalized Myasthenia Gravis
- Kelly Gwathmey, M.D.
- September 21, Time: 11:35am ET
Oral Presentation: Risk Benefit
Analysis of Treatments for Patients with Myasthenia Gravis
- Gordon Smith, M.D., FAAN
- September 21, 11:40am ET
Poster Presentation:
Efgartigimod Demonstrates Consistent Improvements in Generalized
Myasthenia Gravis Across Patient Subgroups, Including Early in
Diagnosis
- Vera Bril, M.D.
- September 21, 8:00 am – 12:00 pm
ET
Poster Presentation: Real-World
Treatment Patterns in Adults with Generalized Myasthenia Gravis
Initiating Intravenous Immunoglobulin in the United States
- Cynthia Qi, argenx
- September 21, 8:00 am – 12:00 pm
ET
Poster Presentation: Trends in
Hospital Admissions and Readmissions for Patients with MG from U.S.
National Research Databases
- Glenn Phillips, Ph.D., argenx
- September 21, 8:00 am – 12:00 pm
ET
See the full Prescribing
Information for VYVGART in the U.S., which includes the below
Important Safety Information. For more information related to
VYVGART in Japan, visit argenx.jp.
Important Safety Information for
VYVGART® (efgartigimod alfa-fcab) intravenous (IV) formulation
(U.S. prescribing information)
What is
VYVGART® (efgartigimod
alfa-fcab)?VYVGART is a prescription medicine used to
treat a condition called generalized myasthenia gravis, which
causes muscles to tire and weaken easily throughout the body, in
adults who are positive for antibodies directed toward a protein
called acetylcholine receptor (anti-AChR antibody positive).What is
the most important information I should know about VYVGART?
VYVGART may cause serious side effects, including:
- Infection. VYVGART may increase the risk
of infection. In a clinical study, the most common infections were
urinary tract and respiratory tract infections. More patients on
VYVGART vs placebo had below normal levels for white blood cell
counts, lymphocyte counts, and neutrophil counts. The majority of
infections and blood side effects were mild to moderate in
severity. Your health care provider should check you for infections
before starting treatment, during treatment, and after treatment
with VYVGART. Tell your health care provider if you have any
history of infections. Tell your health care provider right away if
you have signs or symptoms of an infection during treatment with
VYVGART such as fever, chills, frequent and/or painful urination,
cough, pain and blockage of nasal passages/sinus, wheezing,
shortness of breath, fatigue, sore throat, excess phlegm, nasal
discharge, back pain, and/or chest pain.
- Undesirable immune reactions (hypersensitivity
reactions). VYVGART can cause the immune system to
have undesirable reactions such as rashes, swelling under the skin,
and shortness of breath. In clinical studies, the reactions
were mild or moderate and occurred within 1 hour to 3 weeks of
administration, and the reactions did not lead to VYVGART
discontinuation. Your health care provider should monitor you
during and after treatment and discontinue VYVGART if needed. Tell
your health care provider immediately about any undesirable
reactions.
Before taking VYVGART, tell your health care provider about all
of your medical conditions, including if you:
- Have a history of infection or you think you have an
infection.
- Have received or are scheduled to receive a vaccine
(immunization). Discuss with your health care provider whether you
need to receive age-appropriate immunizations before initiation of
a new treatment cycle with VYVGART. The use of vaccines during
VYVGART treatment has not been studied, and the safety with live or
live-attenuated vaccines is unknown. Administration of live or
live-attenuated vaccines is not recommended during treatment with
VYVGART.
- Are pregnant or plan to become pregnant and are breastfeeding
or plan to breastfeed.
Tell your health care provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
What are the common side effects of VYVGART?The
most common side effects of VYVGART are respiratory tract
infection, headache, and urinary tract infection.
These are not all the possible side effects of VYVGART. Call
your doctor for medical advice about side effects. You may report
side effects to the US Food and Drug Administration at
1-800-FDA-1088.
Please see the full Prescribing Information for
VYVGART and talk to your doctor.
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 Chronic Inflammatory Demyelinating
Polyneuropathy Chronic inflammatory demyelinating
polyneuropathy (CIDP) is a rare and serious autoimmune disease of
the peripheral nervous system. Although confirmation of disease
pathophysiology is still emerging, 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 get worse 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 Multifocal Motor
NeuropathyMultifocal motor neuropathy (MMN) is a rare
chronic, inflammatory, pure motor polyneuropathy leading to slowly
progressive muscle weakness, mainly of the hands and forearms and
lower legs. MMN is associated with increased levels of
immunoglobulin M (IgM) autoantibodies against the ganglioside GM1,
which is widely expressed in the nervous system and important for
nerve conduction. The clinical course of MMN is chronically
progressive without remission. MMN is often misdiagnosed as CIDP
because of the similar clinical features and its progressive nature
but MMN is asymmetric and affects the right and left side of the
body differently.
About
VYVGART
VYVGART (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). VYVGART is not currently approved in any country
for CIDP or MMN, and clinical studies of these conditions are
ongoing.
About argenx
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-and-only approved neonatal Fc receptor (FcRn) blocker in
the U.S., Japan, and the EU. 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.
Media: Kelsey Kirk kkirk@argenx.com
Investors: Beth DelGiacco
bdelgiacco@argenx.com
Forward Looking StatementsThe 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 long-term efficacy, safety
and tolerability of VYVGART® (efgartigimod alfa-fcab) for treatment
of adult patients with generalized myasthenia gravis (gMG) and the
safety, efficacy, and pharmacokinetics of ARGX-117 in adults with
multifocal motor neuropathy. 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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