FDA approves self-injection of Vyvgart Hytrulo

The U.S. Food and Drug Administration has approved a self-injection version of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody-positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

The Vyvgart Hytrulo prefilled syringe is approved as a 20- to 30-second subcutaneous injection administered by a patient, caregiver, or health care professional.

The approval is based on studies evaluating the bioequivalence of the Vyvgart Hytrulo prefilled syringe to Vyvgart Hytrulo in a vial. Human factors validation studies additionally showed that participants with gMG or CIDP, or their caregivers, could safely and successfully prepare and administer Vyvgart Hytrulo with the prefilled syringe.

“Today’s FDA approval provides a new self-injection option across both approved indications in the U.S. that is designed for patients who seek more independence with their treatment,” said Luc Truyen, M.D., Ph.D., the chief medical officer at argenx, in a statement. “Whether patients prefer to receive their treatment in a physician’s office, at home, or while traveling, they can experience treatment on their own terms and continue to benefit from Vyvgart Hytrulo’s favorable safety profile and strong efficacy.”

Approval of self-injectable Vyvgart Hytrulo was granted to argenx.

2025 HealthDay. All rights reserved.