Vyvgart Hytrulo Prefilled Syringe Approved for Self-Administration

The Food and Drug Administration (FDA) has approved a prefilled syringe version of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc; Argenx, Amsterdam, Netherlands) as a self-injection treatment for adults diagnosed with either anti-acetylcholine receptor (AChR) antibody positive generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). Using the prefilled syringe option, patients, their caregivers, or a health care provider (HCP) can administer a 20- to 30-second subcutaneous injection as a single dose, with flexibility for treatment location.

The approval was based on data demonstrating the bioequivalence between Vyvgart Hytrulo delivered as a prefilled syringe and the existing vial formulation. Additionally, patients and their caregivers were found to be able to successfully self-administer Vyvgart Hytrulo as a prefilled syringe based on validation studies in the treatment of gMG and CIDP. The initial approval of Vyvgart Hytrulo for gMG and CIDP was based on results from the phase 2 ADHERE clinical trial (NCT04281472) and the phase 3 ADAPT clinical trial (NCT03669588), respectively.

“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, MD, Director of Neuromuscular Diseases at St. Joseph’s Health. “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.”