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