argenx Announces FDA Approval of VYVGART Hytrulo Prefilled Syringe for Self-Injection in Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy
argenx has received FDA approval for VYVGART Hytrulo prefilled syringe as a self-injection option for treating adult patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). The new administration method allows for a 20-to-30-second subcutaneous injection that can be self-administered by patients after proper training.
This first-in-class FcRn blocker now offers three administration options, providing patients flexibility to receive treatment at home, while traveling, or in healthcare settings. The approval is supported by bioequivalence studies comparing the prefilled syringe to VYVGART Hytrulo in a vial, along with human factors validation studies demonstrating safe administration by patients and caregivers.
The company's patient support program, My VYVGART Path, offers resources including disease education, access support, benefits verification, and financial assistance for eligible patients.
argenx ha ricevuto l'approvazione della FDA per la siringa pre-riempita VYVGART Hytrulo come opzione di auto-iniezione per il trattamento di pazienti adulti affetti da miastenia gravis generalizzata (gMG) e neuropatia periferica demielinizzante infiammatoria cronica (CIDP). Il nuovo metodo di somministrazione consente un'iniezione sottocutanea di 20-30 secondi che può essere auto-somministrata dai pazienti dopo un'adeguata formazione.
Questo bloccante FcRn di prima classe offre ora tre opzioni di somministrazione, fornendo ai pazienti la flessibilità di ricevere il trattamento a casa, durante i viaggi o in contesti sanitari. L'approvazione è supportata da studi di bioequivalenza che confrontano la siringa pre-riempita con VYVGART Hytrulo in fiala, insieme a studi di convalida dei fattori umani che dimostrano una somministrazione sicura da parte dei pazienti e dei caregiver.
Il programma di supporto ai pazienti dell'azienda, My VYVGART Path, offre risorse che includono educazione sulla malattia, supporto per l'accesso, verifica dei benefici e assistenza finanziaria per i pazienti idonei.
argenx ha recibido la aprobación de la FDA para la jeringa precargada VYVGART Hytrulo como opción de auto-inyección para el tratamiento de pacientes adultos con miastenia gravis generalizada (gMG) y neuropatía desmielinizante inflamatoria crónica (CIDP). El nuevo método de administración permite una inyección subcutánea de 20 a 30 segundos que puede ser auto-administrada por los pacientes después de la formación adecuada.
Este bloqueador FcRn de primera clase ahora ofrece tres opciones de administración, proporcionando a los pacientes flexibilidad para recibir tratamiento en casa, mientras viajan o en entornos de atención médica. La aprobación está respaldada por estudios de bioequivalencia que comparan la jeringa precargada con VYVGART Hytrulo en vial, junto con estudios de validación de factores humanos que demuestran una administración segura por parte de pacientes y cuidadores.
El programa de apoyo a pacientes de la empresa, My VYVGART Path, ofrece recursos que incluyen educación sobre la enfermedad, apoyo para el acceso, verificación de beneficios y asistencia financiera para pacientes elegibles.
argenx는 성인 환자의 일반화된 중증 근무력증 (gMG) 및 만성 염증성 탈수초성 다발신경병증 (CIDP) 치료를 위한 자가 주사 옵션으로 VYVGART Hytrulo 프리필드 주사기의 FDA 승인을 받았습니다. 새로운 투여 방법은 적절한 교육 후 환자가 자가 투여할 수 있는 20-30초의 피하 주사를 가능하게 합니다.
이 최초의 FcRn 차단제는 이제 세 가지 투여 옵션을 제공하여 환자들이 자택, 여행 중 또는 의료 환경에서 치료를 받을 수 있는 유연성을 제공합니다. 이 승인은 프리필드 주사기와 바이알의 VYVGART Hytrulo를 비교하는 생물학적 동등성 연구와 환자 및 보호자가 안전하게 투여할 수 있음을 입증하는 인간 요인 검증 연구에 의해 뒷받침됩니다.
회사의 환자 지원 프로그램인 My VYVGART Path는 질병 교육, 접근 지원, 혜택 확인 및 자격이 있는 환자를 위한 재정 지원을 포함한 자원을 제공합니다.
argenx a reçu l'approbation de la FDA pour la seringue préremplie VYVGART Hytrulo comme option d'auto-injection pour le traitement des patients adultes atteints de myasthénie grave généralisée (gMG) et de neuropathie démyélinisante inflammatoire chronique (CIDP). La nouvelle méthode d'administration permet une injection sous-cutanée de 20 à 30 secondes qui peut être auto-administrée par les patients après une formation appropriée.
Ce bloqueur FcRn de première classe offre désormais trois options d'administration, offrant aux patients la flexibilité de recevoir un traitement à domicile, en voyage ou dans des établissements de santé. L'approbation est soutenue par des études de bioéquivalence comparant la seringue préremplie à VYVGART Hytrulo en flacon, ainsi que par des études de validation des facteurs humains démontrant une administration sûre par les patients et les aidants.
Le programme de soutien aux patients de l'entreprise, My VYVGART Path, propose des ressources incluant l'éducation sur la maladie, un soutien à l'accès, la vérification des avantages et une assistance financière pour les patients éligibles.
argenx hat die FDA-Zulassung für die vorgefüllte Spritze VYVGART Hytrulo als Selbstinjektionsoption zur Behandlung von erwachsenen Patienten mit generalisierter Myasthenia gravis (gMG) und chronischer entzündlicher demyelinisierender Polyneuropathie (CIDP) erhalten. Die neue Verabreichungsmethode ermöglicht eine 20- bis 30-sekündige subkutane Injektion, die nach entsprechender Schulung von den Patienten selbst verabreicht werden kann.
Dieser erstklassige FcRn-Blocker bietet jetzt drei Verabreichungsoptionen und ermöglicht es den Patienten, die Flexibilität zu haben, die Behandlung zu Hause, unterwegs oder in Gesundheitseinrichtungen zu erhalten. Die Genehmigung wird durch Bioäquivalenzstudien unterstützt, die die vorgefüllte Spritze mit VYVGART Hytrulo in einer Durchstechflasche vergleichen, sowie durch Studien zur Validierung menschlicher Faktoren, die eine sichere Verabreichung durch Patienten und Pflegepersonen belegen.
Das Patientenunterstützungsprogramm des Unternehmens, My VYVGART Path, bietet Ressourcen, die Bildung über die Krankheit, Unterstützung beim Zugang, Leistungsüberprüfung und finanzielle Unterstützung für berechtigte Patienten umfassen.
- FDA approval expands treatment options with new self-administration capability
- Reduced treatment time with 20-30 second injection
- Increased patient convenience and flexibility with at-home treatment option
- Bioequivalence to existing vial formulation confirmed through studies
- Potential risk of infection reported as side effect
- Possibility of serious allergic reactions
- Risk of injection-related reactions including high blood pressure and pain
Insights
The FDA approval of VYVGART Hytrulo's prefilled syringe for self-injection represents a meaningful advancement in argenx's product strategy for their first-in-class FcRn blocker. This new administration option expands treatment flexibility across both approved indications - generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP).
The prefilled syringe innovation offers significant practical benefits for patients managing these chronic autoimmune conditions. The rapid 20-30 second subcutaneous self-injection enables home administration, potentially increasing treatment adherence while reducing healthcare facility visits and associated costs.
Strategically, this approval strengthens argenx's competitive positioning by addressing a key barrier in biologic treatment - administration convenience. The company's partnership with Halozyme for their ENHANZE drug delivery technology has effectively differentiated VYVGART in the market by enabling high-volume subcutaneous delivery of this biologic.
Notably, the approval pathway leveraged bioequivalence data rather than requiring new efficacy trials, demonstrating argenx's efficient regulatory approach. This delivery innovation aligns with the broader industry trend toward patient-centered care solutions and home administration options.
For argenx investors, this approval represents a positive commercial catalyst that should enhance VYVGART's market penetration and potentially extend its lifecycle, reinforcing the company's leadership position in FcRn biology and autoimmune disease treatment.
- VYVGART, the first-in-class FcRn blocker, now offers three administration options, including self-injection with a prefilled syringe
- Self-injection provides gMG and CIDP patients with flexibility for when and where to receive treatment – at home, while ‘on the go’ or in a healthcare setting
- Approval reflects commitment to innovating the patient experience with individualized, safe and effective therapies
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:
- generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
- chronic inflammatory demyelinating polyneuropathy (CIDP).
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:
- have an infection or fever.
- have recently received or are scheduled to receive any vaccinations.
- have any history of allergic reactions.
- have kidney (renal) problems.
- are pregnant or plan to become pregnant. It is not known whether VYVGART HYTRULO will harm your unborn baby.
- Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART HYTRULO during pregnancy. The purpose of this registry is to collect information about your health and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-855-272-6524 or going to VYVGARTPregnancy.com
- are breastfeeding or plan to breastfeed. It is not known if VYVGART HYTRULO passes into your breast milk.
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:
- Infection. VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART HYTRULO until your infection is gone. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infection: fever, chills, frequent and painful urination, cough, pain and blockage or nasal passages, wheezing, shortness, sore throat, excess phlegm, nasal discharge.
- Allergic reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART HYTRULO injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction: rash, swelling of the face, lips, throat, or tongue, shortness of breath, hives, trouble breathing, low blood pressure, fainting.
- Infusion or injection-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction: high blood pressure, chills, shivering, chest, stomach, or back pain.
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
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.
About argenx
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 franchises. For more information, visit www.argenx.com and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube.
References
1 Behin et al. New Pathways and Therapeutics Targets in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277
This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014).
Contacts
Media:
Colin McBean
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 “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 and the benefit of VYVGART Hytrulo’s safety profile and efficacy; Halozyme’s ENHANZE® drug delivery technology’s ability to develop rapid, high-volume delivery of biologics; its commitment to innovating the patient experience with individualized, safe and effective therapies; its commitment to supporting access for patients to its medicines, including the VYVGART Hytrulo prefilled syringe; 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, including tariffs, export controls, sanctions and other 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 (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.
FAQ
What is the new FDA-approved delivery method for VYVGART Hytrulo (ARGX)?
Which conditions can be treated with VYVGART Hytrulo's new self-injection option (ARGX)?
How was the safety of VYVGART Hytrulo's prefilled syringe (ARGX) validated?
What support does argenx offer for patients using VYVGART Hytrulo (ARGX)?
