Immunology company argenx SE (Euronext Brussels:ARGX) (Nasdaq:ARGX) said on Monday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of VYVGART 1000mg (efgartigimod alfa) for subcutaneous injection as a monotherapy for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) following prior corticosteroid or immunoglobulin treatment.

The European Commission decision on the marketing authorisation application is expected within approximately two months.

VYVGART is the first and only targeted IgG Fc-antibody fragment for CIDP and represents the first novel mechanism of action in CIDP treatment in more than 30 years. The subcutaneous formulation, available as a vial or prefilled syringe, can be administered by patients, caregivers or healthcare professionals and features a flexible dosing regimen.

The CHMP recommendation is supported by positive data from the ADHERE clinical trial, the largest study conducted in CIDP to date. In the trial, 66.5% of patients treated with VYVGART demonstrated clinical improvements in mobility, function and strength, and the study met its primary endpoint with a 61% reduction in relapse risk versus placebo.

The Commission's decision will apply across all 27 European Union Member States, as well as Iceland, Norway and Liechtenstein.