European Commission Approves Efgartigimod Subcutaneous Injection for Forms of CIDP

Jean-Philippe Plançon, PhD, MSc

(Credit: EPODIN)

According to a recent announcement, European Commission (EC) has approved efgartigimod alfa (Vyvgart; Argenx) 1000mg for subcutaneous (SC) injection as a monotherapy to treat adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) following previous treatment with corticosteroids or immunoglobulins.¹

The Commission’s approval followed a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and was based on positive findings from the phase 3 ADHERE trial (NCT04281472). Results of the study showed that patients treated with efgartigimod alfa SC had a 61% reduction (HR, 0.39; 95% CI, 0.25-0.61) in the risk of relapse compared with placebo, meeting the primary end point. Notably, the safety findings were consistent with the known safety profile of the therapy as observed in previous studies.²

"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," Jean-Philippe Plançon, PhD, MSc, president of EPODIN, said in a statement.¹

Efgartigimod, a human IgG1 antibody Fc-fragment, blocks the neonatal Fc receptor (FcRn) and reduces levels of pathogenic IgG autoantibodies. The SC injection, previously approved for other conditions like myasthenia gravis (MG), is available in a vial or prefilled syringe and can be administered by the patient, a caregiver, or a health care professional. Treatment with efgartigimod alfa SC is initiated as a once-weekly regimen and may be adjusted to every other week based on clinical assessment.

READ MORE: Real-World Study Highlights Reduced Disability Progression of CIDP With Immunoglobulin Therapy

“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,” ADHERE investigator Luis Querol, MD, PhD, a neurologist at the Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, said in a statement.¹ “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.”

Argenx noted that this Commission approval will be applied to all 27 European Union Member States, and also to Iceland, Liechtenstein, and Norway. The company also stated that it is working closely alongside local regulatory authorities across the region to ensure that patients who may benefit from the treatment are able to access it as soon as possible. Additionally, this approval marks the second for efgartigimod alfa SC in Europe, first receiving approval as an add-on to standard therapy for treating adult patients with generalized MG who are anti-acetylcholine receptor antibody positive.³

“VYVGART SC is the first therapy with a novel mechanism of action to be approved for this community in more than 30 years,” Luc Truyen, MD, PhD, chief medical officer at argenx, said in a statement.¹ “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.”

REFERENECES
1. argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy. News Release. Argenx. Published June 20, 2025. Accessed June 23, 2025. https://argenx.com/news/2024/argenx-announces-european-commission-approval-of-vyvgart--efgart
2. Argenx reports positive topline data from ADHERE study of Vyvgart Hytrulo in patients with chronic inflammatory demyelinating polyneuropathy. News release. Argenx. July 17, 2023. Accessed June 23, 2025. https://www.globenewswire.com/news-release/2023/07/17/2705309/0/en/argenx-Reports-Positive-Topline-Data-from-ADHERE-Study-of-VYVGART-Hytrulo-in-Patients-with-Chronic-Inflammatory-Demyelinating-Polyneuropathy.html
3. argenx Announces European Commission Approval of Subcutaneous VYVGART® (efgartigimod alfa) for Generalized Myasthenia Gravis. News Release. Argenx. Published November 16, 2023. Accessed June 23, 2025. https://us.argenx.com/news/2023/argenx-announces-european-commission-approval-subcutaneous-vyvgartr-efgartigimod-alfa