FDA Approves Syringe Version of Argenx’s Immune Disorder Drug
April 10, 2025 – Argenx SE, a prominent biotechnology company focused on developing antibody-based therapies for autoimmune diseases and cancer, has received U.S. FDA approval for a prefilled syringe of its blockbuster immune drug, VYVGART Hytrulo. This new approval is intended to give patients a new option to self-inject the treatment at home.
The prefilled syringe complements the existing intravenous formulations. It represents a significant advancement in patient-centric care, offering more flexibility and ease in the management of autoimmune conditions.
The prefilled syringe version received approval for the treatment of adult patients with generalized myasthenia gravis (gMG), a muscle weakening genetic disease, as well as chronic inflammatory demyelinating polyneuropathy (CIDP).
In the words of Luc Truyen, Chief Medical Offices of Argenx, “The Food and Drug Administration approval provides a new self-injection option across both approved indications in the United States that is designed for patients seeking more independence with their treatment. He further added, “Our new prefilled syringe is a vital innovation that offers patients more flexibility to self-administer VYGART Hytrulo”.
VYVGART Hytrulo prefilled syringe is approved for subcutaneous injection, taking just 20 to 30 seconds to administer. It can be given by a patient, healthcare professional, or caregiver. The new approval will tend to allow patients to benefit from VYGART Hytrulo’s favorable safety profile and strong efficacy.
VYGART Hytrulo prefilled syringe version marks an important advancement in patient convenience and treatment accessibility. It will provide CIDP and gMG patients with flexibility for when and where to receive treatment.
Such product launches and approvals are expected to boost the prefilled syringes industry. According to Coherent Market Insights (CMI), the global prefilled syringes market size is projected to reach US$ 10.51 billion in 2032. Global demand for prefilled syringes will likely surge at a CAGR of 5.6% during the forecast period.
“VYGART Hytrulo’s approval in a prefilled syringe version reflects a growing trend toward patient empowerment and home-based care. Such innovations will significantly improve treatment adherence and convenience, marking a transformative step in the evolution of autoimmune therapy delivery,” says a senior analyst at CMI.”
The daily burden of gMG and CIDP from both symptoms and interruption to daily life creates many unseen challenges for patients. This is where convenient and effective treatments, such as Argenx’s VYGART Hytrulo prefilled syringe, can make a meaningful difference.
The new approval introduces an at-home self-administration option for patients, potentially increasing demand for prefilled syringe technologies. It may encourage other pharmaceutical and biotechnology companies to adopt or enhance prefilled syringe systems.
Such treatments can reduce the need for frequent clinic visits. They can be an ideal option for patients seeking to regain time and a sense of normalcy in their daily routine.
The success of VYGART prefilled syringes could tempt other companies to adopt this delivery method for biologics, vaccines, and other drugs. This will further boost growth of the prefilled syringes industry.
Sources:
Company: Argenx
News Outlet: Reuters
