Full Press Release Details
argenx Highlights VYVGART Data at AAN 2025 Setting
New Standard in Sustained Efficacy and
Improved Quality of Life Measures for Patients Living with gMG and CIDP
April 8, 2025, 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 the presentation of 15 abstracts, including an oral presentation, at the 2025 American Academy of Neurology
(AAN) Annual Meeting from April 5 - 9, 2025 in San Diego, CA. The presentations showcase long-term data of VYVGART (IV: efgartigimod
alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) demonstrating sustained disease control of generalized myasthenia
gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) with a favorable safety profile.
argenx also highlighted its commitment to reach
the broader MG patient community with two ongoing label expansion studies in ocular myasthenia gravis (oMG) and seronegative MG (snMG).
In addition, first-in-human data were presented for the company's third clinical candidate, ARGX-119 (MuSK agonist), which is being
evaluated in disorders of the neuromuscular junction (NMJ), including congenital myasthenic syndromes (CMS).
"The data presented at AAN underscore VYVGART
and VYVGART Hytrulo's differentiated efficacy and safety profile, connecting data from our long-term studies to what matters most
to gMG and CIDP patients, which is durable, significant quality of life improvements," said Luc Truyen, M.D., Ph.D., Chief Medical
Officer, argenx. "The extensive data from ADAPT-NXT reinforce the sustained efficacy in patients living with gMG and showcase the
opportunity of individualized VYVGART treatment across fixed cycles or every two- or three-week dosing. Also, our long term ADHERE+ data
highlight the strength of VYVGART Hytrulo to meaningfully impact motor function and muscle strength for patients with CIDP. Overall, the
data we are sharing at AAN reinforce our commitment to the neuromuscular community and further solidify VYVGART as a leading biologic
to redefine patient outcomes."
VYVGART Sets New Benchmark of Sustained Efficacy
and Safety for Patients with gMG
VYVGART Hytrulo Delivers Long-term Functional
Improvements and Favorable Safety Profile for Patients with CIDP
Pipeline Targets Unmet Needs in Underserved
Full study details can be found at 2025 American
Academy of Neurology Abstract Website
See FDA-approved Important Safety Information
below, full Prescribing Information for VYVGART, and full Prescribing Information for VYVGART Hytrulo for additional information.
is VYVGART (efgartigimod alfa-fcab)?
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
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.
may cause serious side effects, including:
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.
taking VYVGART, tell your doctor if you:
are the common side effects of VYVGART?
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
see the full Prescribing Information for VYVGART and talk to your doctor.
is VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)?
HYTRULO 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
HYTRULO is a prescription medicine used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP)
VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO.
VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
HYTRULO may cause serious side effects, including:
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 HYTRULO 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.
taking VYVGART HYTRULO, tell your doctor if you:
are the common side effects of VYVGART HYTRULO?
common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection.
Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation,
bruising, pain, and hives.
not all the possible side effects of VYVGART HYTRULO. 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.
see the full Prescribing Information for VYVGART HYTRULO and talk to your doctor.
VYVGART and VYVGART Hytrulo
(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, which facilitates 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.
is a humanized agonistic monoclonal antibody (mAb) that targets and activates muscle-specific kinase (MuSK) to promote maturation and
stabilization of the neuromuscular junction (NMJ). MuSK is a receptor kinase that has a critical role in the structure and function of
the NMJ. ARGX-119 is being developed as a potential therapy for patients with neuromuscular disease.
Generalized Myasthenia Gravis (gMG)
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
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. Although confirmation
of disease pathophysiology is still emerging, 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
1 Behin et al. New Pathways and Therapeutics Targets
in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277
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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," "believe," "can,"
"continue," "expect," "may," and "will" and include statements argenx makes concerning
the potential impact of VYVGART, VYVGART Hytrulo and ARGX-119 for patients; the data for VYVGART, VYVGART Hytrulo and ARGX-119 as well
as clinical studies, including ADAPT-NXT and ADHERE+; its commitment to reach the broader MG patient community with two ongoing label-expansion
in oMG and snMG; its commitment to improve the lives of people suffering from severe autoimmune diseases; its goal to continue to advance
a robust neuromuscular pipeline of clinical candidates; its view that first-in-human data of ARGX-119 support pipeline-in a-product development