FDA Greenlights Self-Administration of Vyvgart Hytrulo

The U.S. Food and Drug Administration (FDA) has granted approval for a self-injection formulation of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc). This medication is intended for adult patients diagnosed with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor antibodies, as well as for those suffering from chronic inflammatory demyelinating polyneuropathy (CIDP).

The newly approved prefilled syringe allows for subcutaneous injections that can be administered in a span of 20 to 30 seconds, facilitating usage by patients, caregivers, or healthcare professionals. The decision to approve this self-injection method was supported by studies that demonstrated the bioequivalence of the prefilled syringe to the vial version of Vyvgart Hytrulo. Additionally, human factors validation studies indicated that participants with gMG or CIDP, along with their caregivers, were capable of safely and effectively preparing and administering the medication using the prefilled syringe.

According to a statement from argenx, the company responsible for the drug, the FDA's approval presents a new self-injection option for patients seeking greater autonomy in their treatment regimens. The chief medical officer of argenx highlighted the significance of this approval, emphasizing that it allows patients to choose how they receive their treatment--whether in a clinical setting, at home, or while traveling--ensuring they continue to benefit from the favorable safety profile and robust efficacy of Vyvgart Hytrulo.

This approval marks a significant milestone in the management of both gMG and CIDP, potentially improving the quality of life for many patients by facilitating easier access to their treatment.