Amsterdam, the Netherlands –
[04/18/2023]
argenx SE (Euronext & Nasdaq: ARGX), a global immunology
company committed to improving the lives of people suffering from
severe autoimmune diseases, today announced that it will present
six abstracts further demonstrating its long-term commitment to the
generalized myasthenia gravis (gMG) community during the 75th
American Academy of Neurology (AAN) Annual Meeting, which is taking
place from April 22-27, 2023 in Boston, MA. The presentations
include clinical and real-world efgartigimod data that demonstrate
the potential of neonatal Fc receptor (FcRn) blockade in
transforming treatment for gMG and other IgG-mediated autoimmune
diseases.
“Our presentations at AAN will showcase the
depth of evidence we are generating in support of the clinical and
real-world profile of efgartigimod to address the
often-underappreciated needs of people living with gMG,” said Luc
Truyen, M.D. Ph.D., Chief Medical Officer, argenx. “We have a
unique opportunity to recalibrate expectations for patients and
their supporters by setting a new standard for what
‘well-controlled’ means in gMG and across autoimmunity more
broadly.”
Power of Individualized Dosing
from Long-term Extension StudiesThe presentations
include results from the open-label extension studies of VYVGART®
(efgartigimod alfa-fcab) and subcutaneous (SC) efgartigimod
following long-term treatment in ADAPT+ (217.5 patient-years
follow-up) and ADAPT-SC+ (72 patient-years follow-up). Long-term
treatment, administered in individualized dosing cycles, led to
consistent and repeatable reductions in IgG antibody levels and
improved clinical outcomes.
A cross-indication review of the safety profile
of efgartigimod will also be presented across multiple IgG-mediated
autoimmune diseases, reinforcing the consistent safety profile
observed with efgartigimod.
Potential in
Patients Early in gMG
Disease CourseA new exploratory analysis will be
presented from the ADAPT Phase 3 trial showing that a greater
percentage of gMG patients with fewer than three years disease
duration were responders and achieved minimum symptom expression
(MSE) compared with placebo.
New Opportunities
with Patient Support
ProgramsAs part of its commitment to address
access for gMG patients impacted by social determinants of health
challenges, argenx will present quantitative and qualitative
research that identified potential opportunities to expand patient
support program offerings, including the establishment of an
information hotline and symptom tracking app, a patient mentoring
program, an innovative giving strategy and broadened awareness
campaigns of nurse case manager services.
Details for the poster presentations are
as follows:
Title: Long-Term Safety,
Tolerability, And Efficacy of Efgartigimod in Patients with
Generalized Myasthenia Gravis: Concluding Analyses from the
ADAPT+Session Date & Time: Oral Presentation -
Sunday, April 23 at 2:00pm ETPresenter: Dr.
Mamatha PasnoorAbstract Number: S5.006
Title: Long-Term Safety,
Tolerability, and Efficacy of Subcutaneous Efgartigimod PH20 in
Patients with Generalized Myasthenia Gravis: Interim Results of the
ADAPT-SC+ StudySession Date & Time: Poster
Session 1, Sunday, April 23, 8-9 am ETPresenter:
Dr. James F. HowardAbstract Number: P1.5-014
Title: Dose Selection and
Clinical Development of Efgartigimod Ph20 Subcutaneous Inpatients
With Generalized Myasthenia GravisSession Date &
Time: Poster Session 1, Sunday, April 23, 8-9 am
ETPresenter: Dr. George LiAbstract
Number: P1.5-017
Title: Overview of the Safety
Profile from Efgartigimod Clinical Trials in Participants with
Diverse IgG-Mediated Autoimmune DiseasesSession Date &
Time: Poster Session 1, Sunday, April 23, 8-9 am
ETPresenter: Dr. Kelly GwathmeyAbstract
Number: P1.5-001
Title: Efgartigimod
Demonstrates Consistent Improvements in Generalized Myasthenia
Gravis Patients of Shorter Disease DurationSession Date
& Time: Poster Session 1, Sunday, April 23, 8-9 am
ETPresenter: Dr. Vera BrilAbstract
Number: P1.5-015
Title: Patient Support Program
Enhancements In Patients Diagnosed With Generalized Myasthenia
Gravis Facing Social Determinants of Health
ChallengesSession Date & Time: Poster Session
4, Monday, April 24, 8-9 am ETPresenter: Dr. Tom
HughesAbstract Number: P4.9-006
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 months, where muscles
throughout the body may be affected. Patients with confirmed AChR
antibodies account for approximately 85% of the total gMG
population.
About VYVGART®
(efgartigimod
alfa-fcab)VYVGART 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 being studied in adults with primary
immune thrombocytopenia (ITP) and other IgG autoantibody-mediated
diseases.
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 UK, and
Japan. 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.
For further information, please contact:
Media:Erin
Murphyemurphy@argenx.com
Investors:Beth
DelGiaccobdelgiacco@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 argenx’s long-term commitment to
the generalized myasthenia gravis (gMG) community, the potential of
neonatal Fc receptor (FcRn) blockade in transforming treatment for
gMG and other IgG-mediated autoimmune diseases, the expected
long-term safety, tolerability and efficacy of VYVGART®
(efgartigimod alfa-fcab) in adult patients with gMG; and potential
opportunities to expand patient support program offerings. 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 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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