Halozyme :FDA Oks Argenx' VYVGART Hytrulo Prefilled Syringe For Generalized Myasthenia Gravis & CIDP

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

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