Biopharmaceutical company Halozyme Therapeutics Inc (NASDAQ:HALO) announced on the Thursday that it has received approval from the US Food and Drug Administration (FDA) for its VYVGART Hytrulo prefilled syringe for self-injection (efgartigimod alfa and hyaluronidase-qvfc).

The product was approved for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

VYVGART Hytrulo prefilled syringe is intended to be given as a 20-to-30-second subcutaneous injection administered by a patient, caregiver or healthcare professional. Patients are able to self-inject following proper instruction in subcutaneous injection technique.

The single dose prefilled subcutaneous injection was developed as part of argenx's partnership with Halozyme on its ENHANZE drug delivery technology, which allows rapid, high-volume delivery of biologics.

The FDA's approval of VYVGART Hytrulo prefilled syringe for self-injection is supported by data from studies evaluating its bioequivalence to VYVGART Hytrulo in a vial.