Self-Inject Vyvgart Hytrulo Approved

FDA has approved an Argenx BLA for a new option for patients to self-inject Vyvgart Hytrulo prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for treating generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP).

Vyvgart Hytrulo is now approved as a 20-to-30-second subcutaneous injection administered by a patient, caregiver, or healthcare professional. The single-dose product was developed as part of a partnership with Halozyme to use its ENHANZE drug delivery technology, which enables rapid, high-volume delivery of biologics, according to Argenx.

Approval is based on data from studies evaluating its bioequivalence to injectable Vyvgart Hytrulo in a vial, the company says. “In addition, human factors validation studies demonstrated that participants with gMG or CIDP, or their caregivers, safely and successfully administered Vyvgart Hytrulo with the prefilled syringe,” it says.