Full Press Release Details
Highlights FcRn Leadership with Long-term Data and Transformational Patient Outcomes at the American Academy of Neurology 2025 Annual
the Netherlands - March 7, 2025 - argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving
the lives of people suffering from severe autoimmune diseases, today announced clinical trial and real-world data for VYVGART
(efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) will be presented at the
American Academy of Neurology (AAN) Annual Meeting, taking place in San Diego, CA from April 5-9, 2025.
goal is to help people living with rare autoimmune diseases feel and function the way they did before experiencing life with a debilitating
condition. This year at AAN, we are sharing more evidence demonstrating the long-term benefits of VYVGART for patients living with gMG
and CIDP," said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. "Our breadth of data continues to support VYVGART
as a leading biologic. It has a proven ability to achieve minimal symptom expression for gMG patients and reduce CIDP symptoms quickly
while providing improved functional ability, all with a favorable safety profile. We look forward to engaging in the latest science at
AAN to continue pushing the boundaries of helping patients live better."
at AAN will highlight real-world and clinical data demonstrating VYVGART's sustained clinical improvements, including consistent
functional improvement and a favorable safety profile. In addition, presentations support an individualized treatment approach and the
ambition for VYVGART to reach patients earlier in the treatment paradigm.
for oral and poster presentations at AAN are as follows:
| Title | Lead Author | Presentation |
| Long-term Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy: Interim Results From The ADHERE+ Study | Jeffrey Allen | Oral Presentation #002 S:16 Updates on Nerve and Muscle Disorders Monday, April 7 1:12 PM |
| Design of a Phase 3 Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Subcutaneous Efgartigimod PH20 Administered by Prefilled Syringe in Adults with Ocular Myasthenia Gravis | Carolina Barnett-Tapia | Poster #003 Neighborhood 11 Saturday, April 5 11:45 - 12:45 PM |
| Long-Term Safety and Efficacy of Subcutaneous Efgartigimod PH20 in Adult Participants with Generalized Myasthenia Gravis: Interim Results of the ADAPT-SC+ Study | Tuan Vu | Poster #005 Neighborhood 11 Saturday, April 5 11:45 - 12:45 PM |
| Fixed Cycle and Every-Other-Week Dosing of Intravenous Efgartigimod for Generalized Myasthenia Gravis: Part B of ADAPT NXT | Kelly Gwathmey | Poster #004 Neighborhood 11 Saturday, April 5 11:45 - 12:45 PM |
| Hospitalization Outcomes After Efgartigimod Initiation In Patients with Myasthenia Gravis | A. Gordon Smith | Poster #011 Neighborhood 11 Saturday, April 5 11:45 - 12:45 PM |
| A Retrospective Claims Study to Investigate Safety Risks Associated with Chronic Inflammatory Demyelinating Polyneuropathy and the Mediating Effects of Immunoglobulin Treatments | Jana Podhorna | Poster #011 Neighborhood 2 Saturday, April 5 11:45 AM - 12:45 PM |
| Changes In Nonsteroidal Immunosuppressive Treatment Usage Before and After Efgartigimod Initiation in Patients with Myasthenia Gravis | Pushpa Narayanaswami | Poster #015 Neighborhood 11 Saturday, April 5 11:45 - 12:45 PM |
| Combined Analyses of Participants with Anti-Acetylcholine Receptor Seronegative Generalized Myasthenia Gravis Treated with Efgartigimod Across Clinical Studies | Vera Bril | Poster #029 Neighborhood 11 Saturday, April 5 11:45 - 12:45 PM |
| Evaluating the Comparative Effectiveness of Emerging Immunomodulatory Therapies for Patients with Generalized Myasthenia Gravis | A. Gordon Smith | Poster #033 Neighborhood 11 Saturday, April 5 11:45 - 12:45 PM |
| Study Design of Subcutaneous Efgartigimod PH20 in Juvenile Generalized Myasthenia Gravis | Abigail Schwaede | Poster #009 Neighborhood 6 Monday, April 7 5:00 - 6:00 PM |
| Phase 3 Trial Investigating Impact of Intravenous Efgartigimod in Anti-Acetylcholine Receptor Antibody Negative Generalized Myasthenia Gravis | James F. Howard Jr | Poster #032 Neighborhood 11 Monday, April 7 5:00 - 6:00 PM |
| First-in-Human Dose Selection and Pharmacokinetics, Safety, Tolerability, and Immunogenicity of ARGX-119, an Agonist Antibody for Human Muscle-Specific Kinase | Tonke van Bragt | Poster #007 Neighborhood 2 Tuesday, April 8 5:00-6:00 PM |
| Treatment Impact of Efgartigimod PH20 SC in I-RODS Daily Activity Assessment in Patients with Chronic Inflammatory Demyelinating Polyneuropathy: Post hoc Analysis of the Registrational ADHERE Study | Richard Lewis | Poster #025 Neighborhood 11 Tuesday, April 8 5:00 PM - 6:00 PM |
| Investigating the Pharmacodynamics, Injection Speed, and Usability of Subcutaneous Efgartigimod PH20 Administration Using a Prefilled Syringe | Tiffany Hargraves | Poster #026 Neighborhood 11 Tuesday, April 8 11:45 - 12:45 PM |
| Transition From Intravenous Immunoglobulin to Efgartigimod PH20 SC in Participants with Chronic Inflammatory Demyelinating Polyneuropathy: A Phase 4 Study in Progress | Yessar Hussain | Poster #026 Neighborhood 11 Tuesday, April 8 5:00 PM - 6:00 PM |
| COVID-19 Vaccination Response in Participants Across Clinical Trials Investigating Efgartigimod PH20 SC | Ali A. Habib | Poster #029 Neighborhood 11 Tuesday, April 8 11:45 - 12:45 PM |
information on the program is available at www.aan.com/events/annual-meeting-abstracts#subnav.
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
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.
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. |
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.
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. |
are the common side effects of VYVGART?
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.
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)
not use 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:
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 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?
most 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.
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 the US Food and Drug Administration at 1-800-FDA-1088.
see the full Prescribing Information for VYVGART HYTRULO and talk to your doctor.
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, China and Canada 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).
Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART, and
recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology to facilitate subcutaneous
injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the reduction of circulating
IgG. It is the first-approved FcRn blocker administered by subcutaneous injection. VYVGART Hytrulo is the proprietary name in the U.S.
for subcutaneous efgartigimod alfa and recombinant human hyaluronidase PH20. It may be marketed under different proprietary names following
approval in other regions.
Generalized Myasthenia Gravis
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.
Chronic Inflammatory Demyelinating Polyneuropathy
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.
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.
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
et al. New Pathways and Therapeutics Targets in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277
further information, please contact:
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," "engage," "may," and "will" and include statements argenx
makes concerning the potential impact of VYVGART and VYVGART Hytrulo for patients; the data for VYVGART and VYVGART Hytrulo that will
be presented at the upcoming AAN Annual Meeting; its goal of pushing the boundaries of helping patients live better; the planned agenda
for the AAN Annual Meeting; its data showing VYVGART and VYVGART Hytrulo as one of the leading biologics for gMG and CIDP; 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 the development of novel drug therapies; preclinical and clinical trial and product development activities
and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective;
the impact of governmental laws and regulations on its business; its reliance on third-party suppliers, service providers and manufacturers;
inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list
and description of these risks, uncertainties and other risks can be found in argenx's U.S. Securities and Exchange Commission