Interim data suggest long-term treatment with
VYVGART provides improvement in generalized myasthenia gravis (gMG)
disease scores that remains consistent over multiple treatment
cycles
Long-term safety profile of VYVGART treatment
consistent with Phase 3 ADAPT study
VYVGART is the first-and-only approved neonatal
Fc receptor (FcRn) blocker
Breda, the
Netherlands—April
5, 2022—argenx SE (Euronext &
Nasdaq: ARGX), a global immunology company committed to improving
the lives of people suffering from severe autoimmune diseases,
today announced interim results from ADAPT+, an ongoing Phase 3,
open-label, three-year extension study evaluating long-term safety,
tolerability and efficacy of VYVGART® (efgartigimod alfa-fcab) for
the treatment of adults with gMG. The data will be presented today
in an oral presentation at the 74th Annual Meeting of the American
Academy of Neurology (AAN).
“gMG can have a devastating impact on a person
and their ability to lead a fulfilling life. For healthcare
providers treating gMG patients, the ADAPT+ results provide greater
understanding of how long-term treatment with VYVGART could help
their patients overcome some of the daily limitations they face
living with this debilitating disease,” said James F. Howard Jr.,
M.D., Professor of Neurology, Medicine and Allied Health,
Department of Neurology, UNC School of Medicine and principal
investigator for the ADAPT+ trial. “Patients who participated in
ADAPT+ continued to experience consistent efficacy and safety over
a year of treatment, reinforcing the potential benefit this
targeted therapy can offer to this community.”
“The ADAPT+ data continue to strengthen our
belief in the potential of VYVGART to improve the lives of people
impacted by gMG,” said Luc Truyen, M.D., Ph.D., Chief Medical
Officer of argenx. “Together with the robust clinical data already
observed in the ADAPT study, these results further support the
value of VYVGART as an efficacious, well-tolerated targeted
treatment option for a patient community that has been underserved
for years. We are grateful for and humbled by the ongoing
participation of patients, caregivers, and investigators in the
clinical trial, all of whom make continued innovation
possible.”
Highlights of ADAPT+ Interim
Analysis139 patients received at least one dose of VYVGART
in ADAPT+. As of the interim analysis, the mean treatment duration
was 363 days. Efficacy analyses were based on 106 patients who are
anti-acetylcholine receptor (AChR) antibody positive.
Patients who continued on long-term treatment
with VYVGART experienced consistent and clinically meaningful
improvement on both the Myasthenia Gravis Activities of Daily
Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scales.
The safety profile of long-term treatment (up to 10 treatment
cycles) with VYVGART continued to be favorable and consistent with
ADAPT.
- Efficacy is
repeatable,
consistent and predictable
with each subsequent treatment
cycle
- Onset and durability of response
remain consistent with each additional treatment cycle
- Mean improvements on MG-ADL and QMG
scales from five treatment cycles were 5.1 and 4.7, respectively,
and remained consistent between cycles
- Depth of response at increasing
MG-ADL and QMG response thresholds remains consistent with ADAPT
and between ADAPT+ treatment cycles
- 54.6% of patients received ≤5.5
treatment cycles per year based on patients who completed at least
one year of VYVGART treatment at time of interim analysis
- Safety
profile consistent with ADAPT
- VYVGART was
well-tolerated with a consistent safety profile to the ADAPT trial
and during the COVID-19 global pandemic. Majority of adverse events
were mild to moderate in severity.
Details of AAN oral
presentation: 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
Phase 3 ADAPT+
Study DesignThe Phase 3 ADAPT+ trial is a
long-term, single-arm, open-label, multicenter trial evaluating the
efficacy and safety of VYVGART in patients with gMG. Ninety-one
percent (151/167) of ADAPT patients entered the ADAPT+ study. A
total of 106 AChR-Ab+ and 33 AChR-Ab– had received at least one
dose of open-label VYVGART (including 66 ADAPT placebo patients).
The remaining patients were either still responding to treatment
from their last cycle in ADAPT, or dropped out between rollover.
There were at least four weeks between cycles in the ADAPT+ study,
with a maximum of ten cycles. The mean study duration was 363 days,
resulting in 138 patient-years of observation.
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
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 EfgartigimodEfgartigimod 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.
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 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 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
For further information, please
contact: Media:Kelsey
Kirkkkirk@argenx.com
Investors:Beth
DelGiaccobdelgiacco@argenx.com
Michelle Greenblattmgreenblatt@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 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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