Argenx Receives FDA Approval for Self-Injection Prefilled Syringe of VYVGART Hytrulo for gMG and CIDP
Friday, April 11, 2025
argenx SE has announced that the U.S. Food and Drug Administration (FDA) has approved a new self-injection option for its treatment VYVGART® Hytrulo.
VYVGART® (efgartigimod alfa fcab) is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn) to reduce circulating IgG autoantibodies. VYVGART Hytrulo is a subcutaneous formulation that includes efgartigimod alfa and recombinant human hyaluronidase to aid subcu taneous delivery.
gMG is a chronic autoimmune disease where IgG autoantibodies interfere with nerve-to-muscle communication, leading to muscle weakness. Around 85% of those with MG progress to the generalised form within two years, and most have detectable AChR antibodies.
CIDP is a rare autoimmune disorder affecting the peripheral nervous system. It causes symptoms such as muscle weakness, fatigue, and numbness, which can become disabling over time. Without effective treatment, about one-third of patients may eventually require a wheelchair.
The prefilled syringe is intended for adult patients in the United States living with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive, as well as those with chronic inflammatory demyelinating polyneuropathy (CIDP).
The new presentation allows for a 20- to 30-second subcutaneous injection that can be administered by the patient, a caregiver, or a healthcare professional, once proper training is provided. This development aims to give patients greater flexibility in managing their treatment by enabling at-home administration.
argenx stated that this new option aims to support greater independence for patients and reduce the treatment burden by offering a ready-to-use format that fits better with daily life.
The company continues to collaborate with patient communities to address the real-world challenges associated with these chronic conditions.
Source: globenewswire.com
