argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy

June 20, 2025 – Biotechnology, Clinical Trials, Other, Pharmaceutical – European Commission, approvals, argenx, chronic inflammatory demyelinating polyneuropathy, chronic inflammatory diseases

• VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDP
• Approval based on ADHERE clinical trial, the largest study of CIDP patients to date
• First novel mechanism of action for CIDP treatment in more than 30 years.

20 June 2025 — Amsterdam, the Netherlands — argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the European Commission (EC) approved VYVGART® (efgartigimod alfa) 1000mg for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins. VYVGART for SC injection is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional. Treatment is initiated with a weekly dose regimen and may be adjusted to every other week based on clinical evaluation.

“The EC’s decision has been met with hope and enthusiasm by the European Patient Organisation for Dysimmune and Inflammatory Neuropathies (EPODIN). We see the introduction of a new targeted therapy for CIDP as a major step forward for the patient community,” said Jean-Philippe Plançon, President of EPODIN.

CIDP is a rare, debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system. Patients experience a range of disabling mobility and sensory issues, including trouble standing from a seated position, pain and fatigue, and frequent tripping or falling. People living with CIDP can also become wheelchair bound and unable to work as the disease progresses. Currently, 85% of patients require ongoing treatment and nearly 88% of treated patients experience residual impairment and disability.

“CIDP can severely affect quality of life by causing weakness, loss of balance and mobility, numbness and pain in a patient’s arms and legs. For far too long, physicians have had limited options for helping to improve patient outcomes,” said Dr. Luis Querol, M.D., Ph.D., ADHERE Investigator, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. “The approval of VYVGART SC for the treatment of CIDP marks a turning point in clinical practice, as physicians now have access to a new, effective treatment option that, for the first time, precisely targets a key mechanism of disease and provides meaningful functional improvements to patients.”

The EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date. In the study, 66.5% (214/322) of patients treated with VYVGART SC demonstrated evidence of clinical improvement, including in mobility, function and strength. Clinical benefit was seen across all patient subtypes, regardless of prior treatment. ADHERE met its primary endpoint (p<0.0001) demonstrating a 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo. 99% of trial participants elected to participate in the ADHERE open-label extension. The safety results were consistent with the known safety profile of VYVGART SC in previous clinical studies.

“VYVGART SC is the first therapy with a novel mechanism of action to be approved for this community in more than 30 years,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx. “With VYVGART SC, CIDP patients and physicians across Europe will soon have access to an effective novel therapy with a favorable safety profile that has a precise mechanism of action and a convenient self-injection option. This approval further affirms the potential of efgartigimod in IgG-mediated autoimmune diseases.”

The EC approval will apply to all 27 European Union Member States, and also to Iceland, Liechtenstein, and Norway. argenx is working closely with local regulatory authorities across the region to ensure that patients who may benefit from VYVGART SC are able to access the novel treatment as soon as possible.

This regulatory approval is the second for VYVGART SC in Europe, which first received approval as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercialising the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com