Argenx Gains European Commission Approval for Subcutaneous VYVGART in CIDP Treatment
Saturday, June 21, 2025
argenx SE has received approval from the European Commission (EC) for VYVGART® (efgartigimod alfa) 1000mg subcutaneous (SC) injection to treat adults with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP).
CIDP is a rare, immune-mediated neurological disorder affecting the peripheral nervous system. It can cause mobility problems, pain, fatigue, and, in advanced stages, lead to significant disability. Most patients require continuous treatment, and a majority experience long-term impairment despite therapy.
The approval allows use as a monotherapy for patients who have previously received corticosteroids or immunoglobulins.
Available as a vial or prefilled syringe, the treatment can be administered by patients themselves, caregivers, or healthcare professionals. Dosing begins weekly and may shift to every other week based on the patient’s clinical response.
The approval is based on data from the ADHERE clinical trial, the largest study conducted in CIDP to date. The trial showed that 66.5% of patients treated with VYVGART SC experienced improvements in mobility, strength, and function. The treatment significantly reduced the risk of relapse compared to placebo. Nearly all study participants chose to continue treatment in an open-label extension phase. The safety profile was consistent with prior studies of the therapy.
This marks the first European approval of a CIDP treatment with a novel mechanism of action in over three decades. The decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP).
The approval applies to all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. argenx is working with national regulatory authorities to support timely access to the new therapy across the region.
This is the second EC approval for subcutaneous VYVGART in Europe, following its earlier authorisation for use in generalised myasthenia gravis in adult patients who are anti-AChR antibody positive.
Source: globenewswire.com
