Presentations demonstrate leadership in FcRn,
including an oral presentation of data from the ADAPT+ open label
extension study evaluating long-term safety, tolerability and
efficacy of VYVGART® (efgartigimod alfa-fcab) in adult patients
with generalized myasthenia gravis
Regulatory News:
argenx SE (Euronext & Nasdaq: ARGX), a global immunology
company committed to improving the lives of people suffering from
severe autoimmune diseases, today announced that interim data will
be presented from ADAPT+ at the American Academy of Neurology (AAN)
Annual Meeting in Seattle, WA, April 2-7. ADAPT+ is the global
Phase 3 open-label extension study evaluating long-term efficacy,
safety and tolerability of VYVGART® (efgartigimod alfa-fcab) in
adult patients with generalized myasthenia gravis (gMG).
Additional presentations at AAN will include a review of
baseline characteristics from the Company’s pre-approval access
program for VYVGART, as well as data on the treatment burden of gMG
from a cross-sectional study of 152 U.S. adults with a
self-reported gMG diagnosis.
“We are thrilled that our ADAPT+ study has been selected for an
oral presentation at this important neurology forum, and hope these
exciting data will advance healthcare providers’ understanding of
long-term therapeutic outcomes with VYVGART as they continue to
manage their gMG patients,” said Tim Van Hauwermeiren, Chief
Executive Officer of argenx. “We remain as committed as ever to the
gMG community, and look toward to offering deeper insight into the
patient experience so we may best address their unmet needs and
seek to alleviate the burden of this complex, debilitating
disease.”
AAN 2022 Presentations:
Long-term Safety, Tolerability, and Efficacy of Efgartigimod
in Patients with Generalized Myasthenia Gravis: Interim Results of
the ADAPT+ Study Tuesday, April 5, 2022, at 4:06 PM PT
Session: S25: Autoimmune Neurology 2: Clinical Trials and
Treatment; Presentation 004 Presenter: James F. Howard Jr.,
M.D., Professor of Neurology (Neuromuscular Disease), Medicine and
Allied Health, Department of Neurology, The University of North
Carolina at Chapel Hill School of Medicine
Baseline Characteristics and Demographics of Patients
Enrolled in an Expanded Access Program for Efgartigimod in Adult
Patients with Generalized Myasthenia Gravis Saturday, April 2,
2022 from 5:30 PM – 6:30 PM PT Session: P3: Autoimmune
Neurology: Peripheral Nervous System and Muscle 1; Presentation
001, Neighborhood 1 Presenter: Deborah Gelinas, M.D.,
Executive Director, Neuromuscular Medical Affairs, argenx
Treatment Burden According to Patients with Generalized
Myasthenia Gravis Sunday, April 3, 2022 from 5:30 PM – 6:30 PM
PT Session: P6: Neuromuscular Disease: Myasthenia Gravis 1;
Presentation 008, Neighborhood 13 Presenter: Tuan Vu, M.D.,
Professor of Neurology, University of South Florida
The meeting abstracts are available online and can be accessed
through the AAN meeting website at AAN.com. To learn more about
VYVGART, please visit AAN Booth #317 or VYVGART.com.
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 Efgartigimod
Efgartigimod is an antibody fragment designed to reduce
pathogenic immunoglobulin G (IgG) antibodies by binding to the
neonatal Fc receptor and blocking the IgG recycling process.
Efgartigimod is being investigated in several autoimmune diseases
known to be mediated by disease-causing IgG antibodies, including
neuromuscular disorders, blood disorders, and skin blistering
diseases. Efgartigimod is currently approved in the United States
as VYVGART® (efgartigimod alfa-fcab) 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 Gravis
Generalized myasthenia gravis (gMG) is a rare and chronic
autoimmune disease where immunoglobulin G (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 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. 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.
References
- Behin et al. New Pathways and Therapeutics Targets in
Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277
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 expected long-term safety, tolerability and efficacy of
VYVGART® (efgartigimod alfa-fcab) in adult patients with
generalized myasthenia gravis. 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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version on businesswire.com: https://www.businesswire.com/news/home/20220331006063/en/
Media: Kelsey Kirk kkirk@argenx.com Joke Comijn (EU)
jcomijn@argenx.com Investors: Beth DelGiacco
bdelgiacco@argenx.com Michelle Greenblatt
mgreenblatt@argenx.com
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