Full Press Release Details
argenx Announces FDA Approval of
VYVGART Hytrulo Prefilled Syringe for Self-Injection in Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy
April 10, 2025, 11:45 PM 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 the U.S. Food and Drug Administration (FDA) approved a new option for patients to self-inject VYVGART
Hytrulo with a prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia
gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating
polyneuropathy (CIDP).
"Today's FDA approval provides a new
self-injection option across both approved indications in the U.S. that is designed for patients who seek more independence with their
treatment," said Luc Truyen M.D., Ph.D., Chief Medical Officer, argenx. "We understand patients experience MG and CIDP in
different ways, and our prefilled syringe is an important innovation that provides patients with more freedom and flexibility to self-administer
VYVGART Hytrulo. Whether patients prefer to receive their treatment in a physician's office, at home, or while traveling, they can
experience treatment on their own terms and continue to benefit from VYVGART Hytrulo's favorable safety profile and strong efficacy."
VYVGART Hytrulo prefilled syringe for self-injection
is approved as a 20-to-30-second subcutaneous injection administered by a patient, caregiver, or healthcare professional. Patients are
able to self-inject after proper instruction in subcutaneous injection technique. The single dose prefilled subcutaneous injection was
developed as part of argenx's exclusive partnership with Halozyme's ENHANZE drug delivery technology, which
enables rapid, high-volume delivery of biologics.
"I am excited to offer my patients living
with gMG and CIDP the option of the new prefilled syringe for VYVGART Hytrulo," said Dr. Beth Stein, M.D., Director of Neuromuscular
Diseases, St. Joseph's Health, Clifton, NJ. "This new self-injection option will lead to more convenient and flexible administration
for patients, empowering them to decide when and where they receive treatment. A ready-to-use option enhances patient independence and
reduces the time required for treatment, making disease management and control more seamless."
The approval of VYVGART Hytrulo prefilled
syringe for self-injection is supported by data from studies evaluating its bioequivalence to VYVGART Hytrulo in a vial. In
addition, human factors validation studies demonstrated that participants with gMG or CIDP, or their caregivers, safely and
successfully prepared and administered VYVGART Hytrulo with the prefilled syringe. Previous FDA approval of VYVGART Hytrulo for
patients with gMG and CIDP was based on the global Phase 3 ADAPT, ADAPT-SC and ADHERE trials.
"argenx is a trusted partner in the MG
patient community, continuously innovating to meet the evolving needs of patients. This new self-injection option is a natural progression,
empowering individuals to take control of their treatment and working toward achieving a greater sense of normalcy in their lives,"
said Samantha Masterson, President and CEO of the Myasthenia Gravis Foundation of America.
"The daily burden of CIDP from both the
symptoms of the disease and interruption to daily life creates profound unseen challenges for patients," said Lisa Butler, Executive
Director, GBS-CIDP Foundation. "Effective new treatments that reduce the need for frequent clinic visits are a welcome option for
active patients seeking to regain time and a sense of normalcy in their daily routine. Today's news about the approval of argenx's
prefilled syringe for at-home self-injection is a significant step forward for those patients seeking a new treatment option."
Access Support for VYVGART Hytrulo Prefilled Syringe
The argenx patient support program, My VYVGART
Path, can help patients and healthcare providers navigate access. My VYVGART Path resources include disease and product education, access
support and benefits verification, and financial assistance programs for eligible patients. argenx is committed to supporting access
for patients to its medicines, including VYVGART Hytrulo prefilled syringe.
More information is available at VYVGART.com.
See FDA-approved Important Safety Information
below and full Prescribing Information for VYVGART Hytrulo for additional information.
Important Safety Information
What is VYVGART HYTRULO (efgartigimod alfa and
hyaluronidase-qvfc)?
VYVGART HYTRULO is a prescription medicine used to treat adults with:
It is not known if VYVGART HYTRULO is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take VYVGART HYTRULO if you are
allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic
reactions and a decrease in blood pressure leading to fainting.
Before taking VYVGART HYTRULO, tell your healthcare provider
about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
VYVGART HYTRULO can cause side effects which can be serious, including:
The most common side effects of VYVGART HYTRULO
include respiratory tract infection, headache, urinary tract infection, and injection site reactions.
These are not all the possible side effects of VYVGART HYTRULO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see accompanying full Prescribing and Patient Information
for VYVGART HYTRULO.
About VYVGART and VYVGART Hytrulo
VYVGART (efgartigimod alfa fcab)
is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating
IgG autoantibodies. VYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human
hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology to facilitate subcutaneous injection
delivery of biologics. VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART
Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different
proprietary names in other regions.
About Generalized Myasthenia Gravis (gMG)
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
About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic inflammatory demyelinating polyneuropathy
(CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. There is increasing evidence that IgG antibodies play
a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness and a loss of feeling in their
arms and legs that can get worse over time or may come and go. These symptoms can significantly impair a person's ability to function
in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair.
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 and is evaluating its broad
potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic
Behin et al. New Pathways and Therapeutics Targets in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5.
This press release contains inside information within the
meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014).
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 "aim," "are," "can," "continue,"
"may," and "will" and include statements argenx makes concerning the potential impact of the VYVGART Hytrulo
prefilled syringe for self-injection for gMG and CIDP patients, including the increased convenience and flexibility of administration