The United States Food and Drug Administration (FDA) has granted approval for a prefilled syringe of efgartigimod alfa and hyaluronidase-qvfc, enabling adult patients to self-administer Vyvgart Hytrulo for the treatment of two neurological conditions.
The approval covers treatment for generalised myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody positive, as well as for chronic inflammatory demyelinating polyneuropathy (CIDP).
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 FDA approval provides a new self-injection option across both approved indications in the US that is designed for patients who seek more independence with their treatment,” said Dr Luc Truyen, Chief Medical Officer at argenx.
The pharmaceutical company said the development aims to provide patients with greater freedom in managing their conditions, allowing them to choose whether to receive treatment at a doctor’s office, at home, or while travelling.
Enhanced Patient Experience
The newly approved Vyvgart Hytrulo prefilled syringe delivers a 20-to-30-second subcutaneous injection that can be administered by patients themselves after proper instruction in injection technique. Caregivers or healthcare professionals can also administer the treatment.
Dr Beth Stein, Director of Neuromuscular Diseases at St Joseph’s Health in Clifton, New Jersey, welcomed the development: “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.”
She added that the ready-to-use option enhances patient independence and reduces treatment time, “making disease management and control more seamless.”
Technology Partnership
The single-dose prefilled subcutaneous injection was developed through argenx’s exclusive partnership with Halozyme’s ENHANZE drug delivery technology, which facilitates rapid, high-volume delivery of biologics.
FDA approval of the self-injection format is supported by studies demonstrating bioequivalence to Vyvgart Hytrulo in a vial. Additional human factors validation studies showed that participants with gMG or CIDP, or their caregivers, could safely and successfully prepare and administer the treatment using the prefilled syringe.
Patient Community Response
Patient advocacy organisations have responded positively to the approval. Samantha Masterson, President and CEO of the Myasthenia Gravis Foundation of America, described the development as “a natural progression, empowering individuals to take control of their treatment and working toward achieving a greater sense of normalcy in their lives.”
Lisa Butler, Executive Director of the GBS-CIDP Foundation, highlighted the significance for CIDP patients: “The daily burden of CIDP from both the symptoms of the disease and interruption to daily life creates profound unseen challenges for patients. 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.”
Previous FDA approval of Vyvgart Hytrulo for patients with gMG and CIDP was based on the global Phase 3 ADAPT, ADAPT-SC and ADHERE clinical trials.
Reference
- argenx Announces FDA Approval of VYVGART Hytrulo Prefilled Syringe for Self-Injection in Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy. Available at argenx.com/news/2024/argenx-announces-fda-approval-of-vyvgart-hytrulo-prefilled-syrin?utm_source=organic&utm_medium=LI&utm_campaign=PFSInnovation [accessed April 2025]
