The FDA has approved a prefilled syringe formulation of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous self-injection in adult patients with generalized myasthenia gravis who are anti–acetylcholine receptor antibody positive, as well as in adult patients with chronic inflammatory demyelinating polyneuropathy. This formulation offers an additional administration option alongside intravenous infusion and subcutaneous injection via vial.
VYVGART Hytrulo is a neonatal Fc receptor blocker designed to reduce pathogenic IgG autoantibodies. The newly approved prefilled syringe allows for subcutaneous administration over 20 to 30 seconds by patients, caregivers, or health care professionals following appropriate training. The approval was supported by data that demonstrated bioequivalence to the vial formulation and by human factors validation studies which indicated that patients with generalized myasthenia gravis (gMG) or chronic inflammatory demyelinating polyneuropathy (CIDP), or their caregivers, were able to safely and successfully administer the drug.
The product was developed using Halozyme’s ENHANZE® drug delivery technology, which enables rapid, high-volume delivery of biologics. According to argenx, the manufacturer, the prefilled syringe was designed to provide patients with greater autonomy and convenience in treatment administration while maintaining the established safety and efficacy profile of VYVGART Hytrulo.
Previously, regulatory approvals for VYVGART Hytrulo were based on data from the global phase III ADAPT, ADAPT-SC, and ADHERE trials. The company stated that the prefilled syringe option may reduce treatment burden for patients who prefer or require at-home administration.
argenx has also expanded access support through its My VYVGART Path program, which offers product education, benefits verification, and financial assistance for eligible patients. Full prescribing information and safety details are available on the manufacturer’s website.
Common adverse events associated with VYVGART Hytrulo include respiratory tract infection, headache, urinary tract infection, and injection site reactions. Serious risks include infection, hypersensitivity reactions, and infusion-related reactions. VYVGART Hytrulo is not approved for use in pediatric patients.
The product remains subject to standard precautions related to immunosuppression and hypersensitivity. Reporting of adverse effects and participation in the pregnancy exposure registry are encouraged through established channels.
Reference:
argenx. argenx announces FDA approval of VYVGART Hytrulo prefilled syringe for self-injection in generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy [press release]
