From GlobeNewswire: 2025-04-10 17:47:00

The FDA has approved a new self-injection option for VYVGART Hytrulo, a treatment for gMG and CIDP, offering patients flexibility in when and where they receive treatment. Patients can now self-inject the medication with a prefilled syringe, allowing for independence and convenience. This approval reflects the commitment of argenx to innovating the patient experience with safe and effective therapies. The prefilled syringe is administered as a 20-to-30-second subcutaneous injection and was developed in partnership with Halozyme’s ENHANZE® drug delivery technology. Studies have shown the bioequivalence of the prefilled syringe to the vial form of the medication. The approval is supported by data from global Phase 3 trials.

The new self-injection option for VYVGART Hytrulo is seen as a significant step forward for patients with gMG and CIDP, offering more convenient and flexible administration. The option for at-home self-injection empowers patients to take control of their treatment and work towards achieving a greater sense of normalcy in their lives. The prefilled syringe is designed to provide patients with independence and reduce the time required for treatment, making disease management and control more seamless. The approval is supported by previous studies that have demonstrated the safety and success of self-administration with the prefilled syringe.

Patients and healthcare providers can access support for VYVGART Hytrulo prefilled syringe through the argenx patient support program, My VYVGART® Path. The program offers resources for disease and product education, access support, benefits verification, and financial assistance programs for eligible patients. argenx is dedicated to supporting patient access to its medicines, including VYVGART Hytrulo prefilled syringe.



Read more at GlobeNewswire: argenx Announces FDA Approval of VYVGART Hytrulo Prefilled