- First-and-only approved FcRn antagonist for gMG patients by
NMPA
- 68% of anti-AChR antibody positive gMG patients treated with
VYVGART were responders (n=44/65) on the Myasthenia Gravis
Activities of Daily Living (MG-ADL) scale compared with 30% of
patients treated with placebo (n=19/64) (p<0.0001) during the
first treatment cycle in the Phase 3 ADAPT trial
- Zai Lab to seek National Reimbursement Drug List (NRDL)
inclusion for VYVGART
Amsterdam, the Netherlands— June 30, 2023 --
argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited
(Nasdaq: ZLAB; HKEX: 9688) today announced that China’s National
Medical Products Administration (NMPA) has approved the Biologics
License Application (BLA) for VYVGART® (efgartigimod alfa
injection), a first-in-class neonatal Fc receptor (FcRn)
antagonist, as an add on to standard therapy for the treatment of
adult patients with generalized myasthenia gravis (gMG) who are
anti-acetylcholine receptor (AChR) antibody positive. Zai Lab will
now work with the National Healthcare Security Administration
(NHSA) for NRDL inclusion to enable broad access for patients.
“This approval by the NMPA for VYVGART, our sixth approval
globally, is the first-and-only FcRn blocker available for people
living with gMG in China. This is another milestone on our path to
redefine what well-controlled means for gMG patients and
underscores our longstanding commitment to the global gMG
community,” said Tim Van Hauwermeiren, Chief Executive Officer of
argenx. “We celebrate this achievement with our partner, Zai Lab,
who shares our mutual passion to bring needed innovation to people
with gMG in China. We look forward to continuing our partnership as
we further explore efgartigimod in other indications, expanding our
global footprint in one of the world’s fastest growing markets to
reach more people living with severe autoimmune
diseases.”
“We are pleased to have the NMPA’s approval for VYVGART for
intravenous use. This important milestone brings forward a novel
treatment for gMG patients who face many challenges living with
this complex and difficult-to-control autoimmune disease,” said Dr.
Samantha Du, Founder, Chairperson, and Chief Executive Officer of
Zai Lab. “We appreciate the NMPA for their thorough assessment of
VYVGART, recognizing its differentiated profile and the large unmet
medical need in China. In addition to gMG, we are working with
argenx on three registrational programs exploring other
immunoglobulin G (IgG)-related autoimmune indications and are
looking forward to exploring even more indications over time.”
“There are over 200,000 people living with myasthenia gravis
(MG) in China1. Despite the availability of current treatment
options, there remains a significant unmet medical need. The
approval of VYVGART in China marks an important milestone for
patients and provides physicians with a novel, safe and effective
therapy to help improve the quality of life for those in their
care,” said Dr. Chongbo Zhao, M.D., Ph.D., Deputy Director of
Department of Neurology, Huashan Hospital Affiliated to Fudan
University, Director of Working Group of Huashan Rare Disease
Center. “In clinical studies, efgartigimod demonstrated outstanding
characteristics in terms of onset of action, efficacy, and safety,
helping to improve patients' muscle strength and quality of life.
VYVGART, the first-and-only approved FcRn antagonist for gMG
patients in China, has the potential to revolutionize the treatment
landscape for gMG patients in China and we are grateful to Zai Lab
for providing the support for these patients who have been
devastated by this disease for so long.”
The global Phase 3 ADAPT trial met its primary endpoint,
demonstrating that significantly more anti-AChR antibody positive
gMG patients were responders on the Myasthenia Gravis Activities of
Daily Living (MG-ADL) scale following treatment with efgartigimod
compared with placebo (68% vs. 30%; p<0.0001). 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 cycle2.
There were also significantly more responders on the
Quantitative Myasthenia Gravis (QMG) scale following treatment with
efgartigimod compared with placebo (63% vs. 14%; p<0.0001).
Responders were defined as having at least a three-point reduction
on the QMG scale sustained for four or more consecutive weeks
during the first treatment cycle.
VYVGART demonstrated a well-tolerated safety profile in the
ADAPT clinical trial. The most commonly reported adverse reactions
that occurred more frequently with VYVGART than placebo were upper
respiratory tract infections (10.7% following treatment with
efgartigimod vs. 4.8% of placebo) and urinary tract infections
(9.5% vs. 4.8%).
About VYVGART
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).
Zai Lab has an exclusive license agreement with argenx to
develop and commercialize efgartigimod in mainland China, Hong
Kong, Macau, and Taiwan (Greater China).
About Myasthenia Gravis in China
Myasthenia gravis (MG) is a chronic autoimmune disease,
characterized by debilitating and potentially life-threatening
muscle weakness. There are approximately 200,000 people in China
living with the disease1. More than 85% of people with MG progress
to gMG within 18 months; in this generalized form of the disease,
skeletal muscles throughout the body may be affected, resulting in
weakness and early fatigue. Difficulties with double vision, facial
expression, speech, swallowing, and ambulation are frequent and
difficult to manage for patients and treating physicians. In more
life-threatening cases, gMG can affect the muscles responsible for
breathing, which can be fatal. Acetylcholinesterase (AChE)
inhibitors, steroids, immunosuppressants, and IVIg are the mainstay
of treatment in China. However, there is a lack of high-level
evidence-based recommendations for the treatment of MG,
representing significant unmet needs.
1 Nationwide population-based epidemiological study of
myasthenia gravis in Taiwan, 2010.2 Howard JF et al. Lancet Neurol
2021;20(7):526-536.
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
approved neonatal Fc receptor (FcRn) blocker. 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.
About Zai Lab
Zai Lab (Nasdaq: ZLAB; HKEX: 9688) is an innovative,
research-based, commercial-stage biopharmaceutical company based in
China and the United States. Zai Lab is focused on discovering,
developing, and commercializing innovative products that address
medical conditions with significant unmet needs in the areas of
oncology, autoimmune disorders, infectious diseases, and
neuroscience. The Company’s goal is to leverage our competencies
and resources to positively impact human health in China and
worldwide.
For additional information about Zai Lab, including their
products, business activities and partnerships, research, and other
events or developments, please visit www.zailaboratory.com or
follow them at www.twitter.com/ZaiLab_Global.
For further information, please
contact:
Media:Erin MurphyEMurphy@argenx.com
Investors:Alexandra Roy (US)ARoy@argenx.com
Lynn Elton (EU)LElton@argenx.com
argenx 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 approval of VYVGART® (efgartigimod alfa injection) for
Generalized Myasthenia Gravis (gMG) by China’s National Medical
Products Administration (NMPA); argenx’s partnership with Zai Lab
and Zai Lab’s ability to gain National Reimbursement Drug List
(NRDL) inclusion for efgartigimod; the registrational programs
exploring other immunoglobulin G-related autoimmune indications and
possibility of exploring additional indications; 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.
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