Halozyme Therapeutics, Inc. announced that argenx has received U.S. Food and Drug Administration (FDA) approval of VYVGART^® Hytrulo prefilled syringe for self-injection (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

VYVGART^® Hytrulo prefilled syringe for self-injection is approved as a 20-to-30-second subcutaneous injection administered by a patient, caregiver, or healthcare professional. Patients are able to self-inject after proper instruction in subcutaneous injection technique.

The single dose prefilled subcutaneous injection was developed as part of argenx's exclusive partnership with Halozyme on their ENHANZE^® drug delivery technology, which enables rapid, high-volume delivery of biologics

"The FDA approval of VYVGART Hytrulo prefilled syringe represents a significant advancement in treatment options for gMG and CIDP patients, enabling self-administration by patients and potentially further reducing the burden of treatment," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We are delighted that argenx continues to expand use of Halozyme's proven ENHANZE technology to support patient independence and convenience."

The approval of VYVGART^® Hytrulo prefilled syringe for self-injection is supported by data from studies evaluating its bioequivalence to VYVGART^® Hytrulo in a vial. In addition, human factors validation studies demonstrated that participants with gMG or CIDP, or their caregivers, safely and successfully prepared and administered VYVGART^® Hytrulo with the prefilled syringe. Previous FDA approval of VYVGART^® Hytrulo for patients with gMG and CIDP was based on the global Phase 3 ADAPT, ADAPT-SC and ADHERE trials.