Argenx Receives FDA Approval for VYVGART Hytrulo Prefilled Syringe for Self-Injection in gMG and CIDP
Friday, April 11, 2025
argenx SE a global immunology company focused on severe autoimmune conditions, has received approval from the U.S. Food and Drug Administration (FDA) for a new prefilled syringe version of VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc). This allows adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to self-inject the medicine.
The newly approved prefilled syringe is designed to offer patients a more flexible option for treatment, making it possible to receive therapy at home or on the go. It can be administered subcutaneously in just 20 to 30 seconds by the patient, a caregiver, or a healthcare professional, following appropriate training.
Developed in partnership with Halozyme’s ENHANZE® drug delivery technology, the prefilled syringe supports rapid and high-volume delivery of biologics. This ready-to-use format is intended to improve convenience and reduce the time spent receiving treatment, potentially increasing patient independence.
The FDA approval is based on data showing bioequivalence between the prefilled syringe and the vial format of VYVGART Hytrulo. Additional validation studies confirmed that patients with gMG or CIDP, or their caregivers, were able to safely prepare and administer the medicine.
argenx had previously secured FDA approval for VYVGART Hytrulo following results from global Phase 3 studies, including ADAPT, ADAPT-SC, and ADHERE trials.
To assist with access, argenx continues to offer its patient support programme, My VYVGART® Path. The programme includes educational resources, access and benefits support, and financial assistance for eligible patients. Through this initiative, argenx aims to ensure that patients can obtain the treatments they need with fewer barriers.
Source: globenewswire.com
