argenx Receives Health Canada Approval For VYVGART SC As Monotherapy In Adults With Active Chronic Inflammatory Demyelinating Polyneuropathy

Author: Benzinga Newsdesk | November 05, 2025 09:54am

• VYVGART® SC is first and only neonatal Fc receptor blocker approved to treat CIDP
• Authorization is based on global ADHERE study, the largest clinical trial in CIDP to date
• First novel, targeted therapy for CIDP treatment in 30 years

TORONTO, Nov. 5, 2025 /CNW/ - argenx SE (EURONEXT: ARGX) (NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Health Canada has issued a Notice of Compliance authorizing VYVGART SC (efgartigimod alfa injection) as a monotherapy for the treatment of adult patients with active chronic inflammatory demyelinating polyneuropathy (CIDP).  

VYVGART SC is authorized for CIDP as a once weekly 20-30 second subcutaneous injection in a prefilled syringe, offering patients the flexibility to self-administer or receive treatment from a caregiver or healthcare professional—at home, while 'on the go,' or in a clinical setting. With this milestone, VYVGART SC becomes the first innovative treatment for CIDP in more than 30 years, and the first-and-only neonatal Fc receptor (FcRn) blocker authorized in Canada for CIDP. 

CIDP is a rare, debilitating and often progressive autoimmune disorder of the peripheral nervous system. People living with CIDP experience a range of disabling mobility and sensory issues, such as difficulty standing from a seated position, pain, fatigue, and frequent tripping or falling. As the disease progresses, patients may require the use of a wheelchair and may be unable to work or participate in daily activities. Globally, 85% of patients require ongoing treatment and nearly 88% of treated patients continue to experience residual impairment and disability. 

Currently available CIDP treatments include intravenous immunoglobulin (IVIg) and subcutaneous immunoglobulin (SCIg) with CIDP patients accounting for approximately 20% of IVIg/SCIg use in Canada1. Demand for human-derived blood products continues to grow at 7-8% annually in Canada2, underscoring the importance of new, targeted treatment alternatives such as VYVGART SC to help reduce demand and support future supply of blood products. 

The Health Canada authorization is supported by positive results from the ADHERE study, the largest clinical trial conducted to date in CIDP. In this study, 69% (221/322) of patients treated with VYVGART SC, regardless of prior treatment, demonstrated evidence of clinical improvement, including enhanced mobility, function, and strength. The study met its primary endpoint (p<0.0001), showing a 61% reduction (HR: 0.39, 95% CI: 0.25; 0.61) in the risk of relapse versus placebo. The safety results were generally consistent with the known safety profile of VYVGART in previous clinical studies and real-world use. Nearly all (99%) participants chose to participate in the ADHERE+ open-label extension study. 

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