Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused,
innovative, commercial-stage, global biopharmaceutical company,
today announced that its partner argenx SE (Euronext & Nasdaq:
ARGX), a global immunology company committed to improving the lives
of people suffering from severe autoimmune diseases and cancer,
today announced that the U.S. Food and Drug Administration (FDA)
has approved VYVGART™ (efgartigimod alfa-fcab) for the treatment of
generalized myasthenia gravis (gMG) in adult patients who are
anti-acetylcholine receptor (AChR) antibody positive. These
patients represent approximately 85% of the total gMG population1.
With this regulatory milestone, VYVGART is the first and only
FDA-approved neonatal Fc receptor (FcRn) blocker.
“Today is the start of a new era for argenx and the gMG
community as we honor our commitment to bring forward an innovative
treatment option for people living with this debilitating disease.
The approval of VYVGART represents many achievements: our first
approved product; the first and only FDA-approved neonatal Fc
receptor blocker; and the first approved therapy designed to reduce
pathogenic IgGs, an underlying driver of gMG,” said Tim Van
Hauwermeiren, Chief Executive Officer of argenx. “Importantly, we
want to thank the patients, supportive caregivers, investigators
and study teams who participated in the ADAPT trial, as well as our
partners and dedicated employees for their hard work and
collaboration – all of whom made this milestone possible.
“Our highly motivated commercial team is activated and ready to
deliver VYVGART to patients. We believe the field of autoimmunity
is on the precipice of an evolution, and we hope that this will be
the first of many VYVGART launches, allowing us to help improve the
lives of patients around the world,” continued Mr. Van
Hauwermeiren.
“We congratulate our partner argenx for this first approval,”
said Dr. Samantha Du, Founder, Chairperson and Chief Executive
Officer of Zai Lab. “With an estimated 200,000 patients living with
gMG in China, we see a great need to bring efgartigimod to Chinese
patients with this autoimmune disease as expeditiously as possible.
We will work closely with the China National Medical Products
Administration (NMPA) to accelerate access for these patients with
unmet medical needs. Efgartigimod has the potential to be the
first-in-class FcRn therapy in China for gMG.”
Generalized myasthenia gravis is a rare and chronic
neuromuscular disease characterized by debilitating and potentially
life-threatening muscle weakness. VYVGART is a human IgG1 antibody
fragment that binds to FcRn, resulting in the reduction of
circulating immunoglobulin G (IgG) antibodies. The action of AChR
autoantibodies at the neuromuscular junction is a key driver of
gMG2.
Proven clinical efficacy and safety profile
The approval of VYVGART is based on results from the global
Phase 3 ADAPT trial, which were published in the July 2021 issue of
The Lancet Neurology. The ADAPT trial met its primary endpoint,
demonstrating that significantly more anti-AChR antibody positive
gMG patients were responders on the MG-ADL scale following
treatment with VYVGART 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 cycle.
There were additionally significantly more responders on the
Quantitative Myasthenia Gravis (QMG) scale following treatment with
VYVGART 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 had a demonstrated safety profile in the ADAPT clinical
trial. The most common adverse events in ADAPT were respiratory
tract infection (33% vs 29% placebo), headache (32% vs 29%
placebo), and urinary tract infection (10% vs. 5% placebo).
Marketing Authorization Applications for efgartigimod for the
treatment of gMG are currently under review with Japan’s
Pharmaceuticals and Medical Devices Agency (PMDA) and the European
Medicines Agency (EMA), with anticipated decisions from each agency
in the first quarter and second half of 2022, respectively.
See Important Safety Information and full Prescribing
Information below for additional information.
IMPORTANT SAFETY
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 Phase 3 ADAPT Trial
The Phase 3 ADAPT trial was a 26-week randomized, double-blind,
placebo-controlled, multi-center, global trial evaluating the
safety and efficacy of VYVGART in adult patients with gMG. A total
of 167 adult patients with gMG in North America, Europe and Japan
enrolled in the trial. Patients were randomized in a 1:1 ratio to
receive VYVGART or placebo, in addition to stable doses of their
current gMG treatment. ADAPT was designed to enable an
individualized treatment approach with an initial treatment cycle
followed by subsequent treatment cycles based on clinical
evaluation. The primary endpoint was the comparison of percentage
of MG-ADL responders in the first treatment cycle between VYVGART
and placebo treatment groups in the anti-AChR antibody positive
population.
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 IgG. 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-AChR antibody positive.
About Generalized Myasthenia Gravis
Generalized 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 Zai Lab
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is a patient-focused,
innovative, commercial-stage, global biopharmaceutical company
focused on developing and commercializing therapies that address
medical conditions with unmet needs in oncology, autoimmune
disorders, infectious diseases, and neuroscience. To that end, our
experienced team has secured partnerships with leading global
biopharmaceutical companies in order to generate a broad pipeline
of innovative marketed products and product candidates. We have
also built an in-house team with strong product discovery and
translational research capabilities and are establishing a pipeline
of proprietary product candidates with global rights. Our vision is
to become a leading global biopharmaceutical company, discovering,
developing, manufacturing, and commercializing our portfolio in
order to impact human health worldwide.
For additional information about the company, please visit
www.zailaboratory.com or follow us at
www.twitter.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains statements about future
expectations, plans and prospects for Zai Lab, including, without
limitation, statements regarding the prospects of and plans for
commercializing efgartigimod in the Greater China region. These
forward-looking statements may contain words such as “aim,”
“anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,”
“goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,”
“would” and other similar expressions. Such statements constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements are not statements of historical fact, nor are they
guarantees or assurances of future performance. Forward-looking
statements are based on our expectations and assumptions as of the
date of this press release and are subject to inherent
uncertainties, risks, and changes in circumstances that may differ
materially from those contemplated by the forward-looking
statements. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including but not limited to (1) our ability to
successfully commercialize and generate revenue from our approved
products, (2) our ability to finance our operations and business
initiatives and obtain funding for such activities, (3) our results
of clinical and pre-clinical development of our product candidates,
(4) the content and timing of decisions made by the relevant
regulatory authorities regarding regulatory approvals of our
product candidates, (5) the effects of the novel coronavirus
(COVID-19) pandemic on our business and general economic,
regulatory, and political conditions, and (6) the risk factors
identified in our most recent annual or quarterly report and in
other reports we have filed with the U.S. Securities and Exchange
Commission. We anticipate that subsequent events and
developments will cause our expectations and assumptions to change,
and we undertake no obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events, or otherwise, except as may be required by law.
These forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
For more investor-related information about Zai Lab, please go
to www.SEC.gov or visit www.zailaboratory.com.
References
1 Behin et al. New Pathways and Therapeutics Targets in
Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277
2 Howard JF Jr, Utsugisawa K, Benatar M, et al. Safety and
efficacy of efficacy of eculizumab in anti-acetylcholine receptor
antibody-positive refractory generalised myasthenia gravis
(REGAIN): a phase 3, randomised, double-blind, placebo-controlled,
multicenter study. Lancet Neurol. 2017; 16: 976-86
For more information, please contact:
Investor Relations: Ron
Aldridge / Lina Zhang+1 (781) 434-8465 / +86 136 8257
6943ronald.aldridge@zailaboratory.com / lina.zhang@zailaboratory.com
Media: Danielle Halstrom / Xiaoyu
Chen+1 (215) 280-3898 / +86 185 0015
5011danielle.halstrom@zailaboratory.com / xiaoyu.chen@zailaboratory.com
Zai Lab Limited
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