Argenx announces European Commission approval of VYVGART subcutaneous injection

argenx (ARGX) announced that the European Commission approved VYVGART 1000mg for subcutaneous injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy 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 approval follows a positive recommendation from the Committee for Medicinal Products for Human Use and is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date. In the study, 66.5% 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 demonstrating a 61% reduction 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.