VYVGART® Hytrulo is a novel self-injection option approved by the United States Food and Drug Administration (FDA) for the treatment of adults with generalised myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) who test positive for anti-acetylcholine receptor (AChR) antibodies. It is manufactured by argenx SE, a global immunology company.
gMG and CIDP are rare autoimmune diseases involving Immunoglobulin G (IgG) antibodies that disrupt nerve-muscle communication. Both conditions cause progressive muscle weakness and fatigue. One-third of the patients with CIDP may eventually require a wheelchair if treatment is not received. About 85% of MG patients develop gMG in less than 24 months.
VYVGART® Hytrulo is delivered via a prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) and has been authorized for 20-30 seconds of subcutaneous injection by a healthcare professional, caregiver, or patient. This single-dose prefilled injection was developed in collaboration with argenx and Halozyme’s ENHANZE® drug delivery technology.
VYVGART®, also known as efgartigimod alfa, is a first-in-class human IgG1 antibody fragment that decreases levels of circulating IgG antibodies by binding to the neonatal Fc receptor (FcRn). Hytrulo is a subcutaneous formulation that combines VYVGART® with recombinant human hyaluronidase PH20 (rHuPH20).
This approval is mainly based on data from tests assessing this prefilled syringe’s bioequivalence to VYVGART® Hytrulo in a vial, which justifies the approval of the product for self-injection. Moreover, human factors validation studies showed that patients with gMG or CIDP or those who cared for them prepared and delivered VYVGART® Hytrulo using the prefilled syringe in a safe and effective manner. Phase 3 Advancing Neurological Disease Treatment Access for Patients (ADAPT), Advancing Neurological Disease Treatment Access for Patients – Subcutaneous (ADAPT-SC), and Advancing the Development of Health Outcomes for Rare Disease Evaluation (ADHERE) clinical trials served as the foundation for the FDA’s prior approval of VYVGART® Hytrulo for gMG and CIDP patients.
The most common adverse effects of VYVGART® Hytrulo were headache, injection site reactions, urinary tract infections, and respiratory tract infections. Before using VYVGART® Hytrulo, the healthcare provider should ask patients about current infections, fever, allergies, kidney problems, pregnancy, plans to become pregnant, and breastfeeding.
The FDA approval offers a self-injection option for gMG and CIDP, giving patients greater independence and flexibility. According to argenx Chief Medical Officer Luc Truyen, M.D., Ph.D., “the prefilled syringe allows treatment at home, in clinics, while travelling and supporting personalized care with VYVGART® Hytrulo’s proven efficacy and safety.”
Dr. Beth Stein (M.D., Director of Neuromuscular Diseases, St. Joseph’s Health, Clifton, NJ) welcomes the new VYVGART® Hytrulo prefilled syringe, highlighting its convenience and flexibility for gMG and CIDP patients. The self-injection option empowers patients to choose when and where to receive treatment, promoting independence and streamlining disease management with a ready-to-use solution.
Lisa Butler of the GBS-CIDP Foundation said that CIDP significantly disrupts daily life. She welcomes argenx’s newly approved prefilled syringe for at-home self-injection, calling it a major step forward. This option offers effective treatment while reducing clinic visits, helping patients regain time and restore a sense of normalcy.
Reference: Argenx. argenx Announces FDA Approval of VYVGART Hytrulo Prefilled Syringe for Self-Injection in Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy. Published April 10, 2025. Accessed April 17, 2025. https://argenx.com/news/2024/argenx-announces-fda-approval-of-vyvgart-hytrulo-prefilled-syrin
