The U.S. Food and Drug Administration (FDA) has approved nemolizumab for use in moderate to severe atopic dermatitis, Galderma said in a press release. The European Medicines Agency (EMA) has made a similar decision. The drug is a humanized monoclonal antibody to the interleukin-31 receptor A and is already used for nodular prurigo. It is intended for patients with uncontrolled atopic dermatitis aged 12 years and older in combination with topical glucocorticoids and/or calcineurin inhibitors.
The registration was prompted by the results of the third phase of the ARCADIA trial, which involved 1,728 patients. After five subcutaneous injections of nemolizumab at four-week intervals in combination with topical therapy, patients either experienced a resolution of skin changes or a reduction in the severity and area of eczema according to the EASI scale by at least 75 percent.
