argenx Receives Positive CHMP Opinion for VYVGART SC Injection for CIDP

On April 28, 2025, argenx SE, a prominent global immunology company noted for its dedication to improving the lives of people with severe autoimmune disorders, disclosed significant strides in treating chronic inflammatory demyelinating polyneuropathy (CIDP). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has advocated for the European Commission (EC) to approve VYVGART® (efgartigimod alfa) for subcutaneous injection. This recommendation is aimed at adult patients experiencing either progressive or relapsing forms of active CIDP who have previously been treated with corticosteroids or immunoglobulins.

VYVGART® stands out as the first and only targeted IgG Fc-antibody fragment available for CIDP, marking a novel treatment mechanism in over 30 years. According to Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx, this positive CHMP opinion represents a crucial advancement towards delivering a groundbreaking treatment to patients across Europe, offering meaningful functional improvements to those living with CIDP.

The proposed VYVGART® treatment comes in the form of a subcutaneous injection, available in vials or pre-filled syringes, allowing for administration by the patient, a caregiver, or a healthcare professional. The treatment begins with a weekly dosing regimen, adjustable to every other week depending on clinical evaluations. The endorsement by CHMP is primarily based on the ADHERE clinical trial results, the largest study ever conducted on CIDP patients. The trial showed that 66.5% of patients treated with VYVGART® exhibited clinical improvement, including enhanced mobility and strength. The primary endpoint of the study demonstrated a 61% reduction in the risk of relapse compared to a placebo. Notably, the safety profile of VYVGART® was consistent with previous studies.

Jean-Philippe Plançon, President of the European Patient Organisation for Dysimmune and Inflammatory Neuropathies (EPODIN), expressed optimism about this development. For the CIDP patient community, the CHMP’s recommendation heralds renewed hope for better treatment options and an enhanced quality of life.

The CHMP's positive opinion serves as a scientific recommendation for marketing authorization, which forms the basis for the EC’s final decision on the CIDP application for subcutaneous VYVGART®. The EC's decision will affect all 27 European Union Member States, as well as Iceland, Norway, and Liechtenstein. VYVGART® is already approved as an adjunct to standard therapy for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody positive.

The ADHERE trial was a rigorously conducted multicenter, randomized, double-blind, placebo-controlled study. It involved 322 adult CIDP patients, with 130 based in Europe. Participants were either off treatment or undergoing immunoglobulin therapy or corticosteroids. The study included an open-label stage followed by a randomized, placebo-controlled stage. To qualify, patients had to exhibit active disease with clinically significant worsening shown through CIDP clinical assessments such as INCAT or I-RODS. Those who demonstrated improvement with VYVGART® could proceed to the next trial stage. Following the study, patients had the option to enter an open-label extension to continue receiving VYVGART®.

CIDP is a rare autoimmune disease affecting the peripheral nervous system, causing fatigue, muscle weakness, and sensory loss in limbs, significantly impacting daily functioning. Without intervention, one-third of CIDP patients may require a wheelchair. Approximately 31,413 individuals in the European Union live with CIDP.

Efgartigimod, the active component of VYVGART®, reduces harmful IgG antibodies by interfering with IgG recycling processes. It’s under investigation for several autoimmune diseases and is available in both intravenous and subcutaneous formulations. In August 2022, it received EC approval for intravenous use in treating gMG patients who are AChR antibody positive.

argenx is a leading immunology company focused on developing antibody-based therapies for severe autoimmune diseases, working closely with academic researchers to advance its diverse portfolio.