VYVGART® now approved in Japan
for both generalized myasthenia gravis and primary immune
thrombocytopenia (ITP)
Regulatory decision in Japan represents first
global approval for VYVGART in ITP
March 26, 2024 7:00 AM CET
Amsterdam, the Netherlands –
argenx SE (Euronext & Nasdaq: ARGX), a global immunology
company committed to improving the lives of people suffering from
severe autoimmune diseases, today announced that Japan’s Ministry
of Health, Labour and Welfare (MHLW) approved VYVGART (efgartigimod
alfa) for intravenous (IV) use in adults with primary immune
thrombocytopenia (ITP).
“argenx is on a mission to deliver
transformative medicines for people living with severe autoimmune
disease,” said Tim Van Hauwermeiren, Chief Executive Officer of
argenx. “We have always believed VYVGART has the potential to treat
many IgG-mediated autoimmune diseases, and now patients in Japan,
who have been waiting for a new treatment option, have one for ITP.
My sincere thanks to all of those who contributed to today’s
milestone approval in Japan – it takes true collaboration to bring
real innovation for the millions of patients around the world
living with rare autoimmune disease. And our work has only just
begun.”
“ITP is a severe, debilitating autoimmune
disease, and ITP patients typically experience a significantly
lower quality of life,” said Luc Truyen, M.D., Ph.D., Chief Medical
Officer of argenx. “Physicians now treat ITP via a trial-and-error
approach – or by cycling through current therapies. By reducing
circulating autoantibodies, VYVGART is uniquely designed to serve
as a precision intervention that targets the underlying disease
biology of ITP. We are grateful to all of those who contributed to
advancing our understanding of the disease so that we could bring
VYVGART to patients in Japan.”
The approval of VYVGART is based on results from
the global Phase 3 ADVANCE-IV trial, which were published in the
September 2023 issue of The Lancet. ADVANCE successfully met its
primary endpoint, demonstrating that a higher proportion of chronic
ITP patients receiving VYVGART achieved a sustained platelet count
response compared to placebo. VYVGART demonstrated rapid onset of
effect in chronic and persistent ITP patients, as well as a 51%
response rate on the International Working Group (IWG) score, which
is a measure developed by the world’s leading experts on ITP and
highly relevant to clinical care. Primary endpoint responders were
observed across patient types regardless of age, disease severity,
time since diagnosis, prior ITP treatment or background medication.
VYVGART was well-tolerated in this 24-week study and the observed
safety and tolerability profile was consistent with previous
clinical trials.
Phase 3 ADVANCE Trial
The ADVANCE trial enrolled 131 adult patients
with chronic and persistent ITP. Patients were heavily pretreated
and 67% of patients had received three or more prior ITP therapies,
including 59% who had prior thrombopoietin receptor agonist
(TPO-RAs) experience, 34% with prior rituximab experience and 37%
with a history of splenectomy. Patients were insufficiently
controlled at baseline with mean platelet counts of 17x109/L across
all patients. Of patients who completed the full ADVANCE study, 94%
(63/67) of VYVGART-treated patients and 97% (38/39) of placebo
patients continued to the ADVANCE+ open-label extension study.
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.
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).
IMPORTANT SAFETY INFORMATION Do
not use VYVGART if you have a serious allergy to efgartigimod alfa
or any of the other ingredients in VYVGART. VYVGART can cause
serious allergic reactions and a decrease in blood pressure leading
to fainting.
VYVGART may cause serious side effects,
including:
- Infection. VYVGART
may increase the risk of infection. The most common infections were
urinary tract and respiratory tract infections. Signs or symptoms
of an infection may include 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.
- Allergic Reactions
(hypersensitivity reactions). VYVGART can cause allergic
reactions such as rashes, swelling under the skin, and shortness of
breath. Serious allergic reactions, such as trouble breathing and
decrease in blood pressure leading to fainting have been reported
with VYVGART.
- Infusion-Related
Reactions. VYVGART can cause infusion-related reactions.
The most frequent symptoms and signs reported with VYVGART were
high blood pressure, chills, shivering, and chest, abdominal, and
back pain.
Tell your doctor if you have signs or symptoms
of an infection, allergic reaction, or infusion-related reaction.
These can happen while you are receiving your VYVGART treatment or
afterward. Your doctor may need to pause or stop your treatment.
Contact your doctor immediately if you have signs or symptoms of a
serious allergic reaction.
Before taking VYVGART, tell your doctor
if you:
- take any medicines, including
prescription and non-prescription medicines, supplements, or herbal
medicines,
- have received or are scheduled to
receive a vaccine (immunization), or
- have any allergies or medical
conditions, including if you are pregnant or planning to become
pregnant, or are breastfeeding.
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 Immune
Thrombocytopenia
Immune thrombocytopenia (ITP) is an autoimmune
disorder where immunoglobulin G (IgG) autoantibodies destroy
platelets and reduce platelet production, which can lead to an
increased risk of excessive bleeding and bruising. In severe cases,
frequent bleeding events can cause anemia or even brain hemorrhage
in rare cases. ITP is also associated with debilitating fatigue and
significant impacts on mental health, including anxiety, fear and
depression. Many ITP patients are inadequately controlled on
current therapies so there remains a significant unmet need for
additional treatment options.
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 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). VYVGART is being studied in adults with primary
immune thrombocytopenia (ITP) and other IgG autoantibody-mediated
diseases. VYVGART has been approved for adults with ITP only in
Japan at this time.
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 approved neonatal Fc
receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK,
Canada and China. 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.
Contacts Media:
Ben PetokBpetok@argenx.com
Investors:
Alexandra Roy (US) aroy@argenx.com
Lynn Elton (EU) lelton@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 “aims,”
“believe,” “committed” or “potential” and include statements argenx
makes concerning its mission to deliver transformative medicines
for people living with severe autoimmune disease; its belief that
VYVGART has the potential to treat many IgG-mediated autoimmune
diseases such as ITP; the potential impact of VYVGART for ITP
patients; and its goal of translating immunology breakthroughs into
a world-class portfolio of novel antibody-based medicines. 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, including but
not limited to, the results of argenx’s clinical trials,
expectations regarding the inherent uncertainties associated with
development of novel drug therapies, preclinical and clinical trial
and product development activities and regulatory approval
requirements, the acceptance of our products and product candidates
by our patients as safe, effective and cost-effective, and the
impact of governmental laws and regulations on our business. 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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