argenx SE (ARGX) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended European Commission approval of VYVGART 1000mg (efgartigimod alfa). This subcutaneous (SC) injection is proposed as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP). It is intended for use after prior treatment with corticosteroids or immunoglobulins.
VYVGART for subcutaneous 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 CHMP recommendation is based on positive results from the ADHERE clinical trial. In the ADHERE study, 66.5% (214/322) of patients treated with VYVGART, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function and strength. ADHERE met its primary endpoint demonstrating a 61% reduction in the risk of relapse versus placebo.
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